DePuy Synthes Mitek FMS Duo
DePuy Synthes · Model Mitek FMS Duo
FMS Duo shaver/pump combination irrigation system. It is designed to improve visualization and distension while controlling pressure during arthroscopic surgery. The Flow compensator cycle is activated when a shaver is in rotation and the pressure cycle red pedal aids in field of view obstruction. This product is intended for surgery in the shoulder, knee, ankle, elbow, wrist, and hip.
Key tips
- ·Never defeat or bypass a return-electrode monitoring (REM) alarm to finish a case - it's a direct burn risk.
- ·Verify OR table battery backup - a table that loses power mid-procedure is a real, documented incident type.
- ·Track surgical light lamp-hours rather than waiting for failure - a sudden failure mid-case is avoidable.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Will not reach or hold set joint / cavity pressure
HighSymptoms: Pressure droops or overshoots, poor distension, pressure or flow alarm.
Root cause: Pump-head / roller wear, a pressure-sensor fault, a leak in the tubing / inflow-outflow, or a blocked cannula.
Tubing / cassette-detection fault
MediumSymptoms: Cassette / tubing not recognised, will not prime, leaks at the pump head.
Root cause: Cassette-detection switch or worn pump-head seals.
Outflow / suction-control fault
MediumSymptoms: Poor outflow, cannot clear debris, outflow alarm.
Root cause: Outflow pump / valve or a blocked suction line.
Shaver / handpiece fault (shaver systems)
MediumSymptoms: Blade will not oscillate / rotate, weak cut, handpiece not recognised, footswitch dead.
Root cause: Worn shaver handpiece / motor, or its cable / footswitch.
Display / control fault
LowSymptoms: Unresponsive touchscreen or keys, will not power on.
Root cause: Display / control board or power supply.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Pump-head rollers / seals
Class Periodic replacementRel. cost $$R&R Moderate
Pressure sensor / transducer
Class Major service partRel. cost $$R&R Moderate
Cassette-detection switch
Class Periodic replacementRel. cost $$R&R Moderate
Shaver handpiece / motor (shaver systems)
Class Periodic replacementRel. cost $$$R&R Moderate
Footswitch
Class Periodic replacementRel. cost $$R&R Fairly easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Pump-head rollers / seals | Periodic replacement | $$ | Moderate |
| Pressure sensor / transducer | Major service part | $$ | Moderate |
| Cassette-detection switch | Periodic replacement | $$ | Moderate |
| Shaver handpiece / motor (shaver systems) | Periodic replacement | $$$ | Moderate |
| Footswitch | Periodic replacement | $$ | Fairly easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Pre-case functional check
- ·Electrosurgical return-electrode cable inspection
- ·Table hydraulic / mechanical inspection
- ·Annual electrical safety test and full PM
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Will not hold set pressure / poor distension
- Fit a fresh tubing set / cassette and re-prime.
- Confirm the inflow and outflow cannulae are patent and connections are tight.
- Run the pump self-test and verify the set pressure against a gauge if possible.
- Inspect the pump-head rollers / seals for wear.
- Replace the pump head or pressure sensor as isolated.
Symptom: Shaver will not run (shaver systems)
- Swap the shaver handpiece and cable.
- Check the footswitch and its connection.
- Confirm the console recognises the handpiece.
- Test forward / reverse / oscillate modes.
- Replace the handpiece or refer the console output as isolated.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Operating rooms
- Procedure rooms
- Interventional suites
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- RECALL
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- RECALL
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
- RECALL
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
- RECALL
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
- RECALL
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
- RECALL
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
- RECALL
Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
- RECALL
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- RECALL
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
- RECALL
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
- RECALL
Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
- RECALL
Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode
- RECALL
Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- RECALL
Incorrect suture configuration
- RECALL
Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.
- RECALL
Metal debris in the shaft component of the device
- RECALL
Product sterility may be compromised due to breach in sterile packaging
- RECALL
Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility
- RECALL
The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- RECALL
The device may contain one strand of suture instead of two strands
- RECALL
Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
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