MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON AR FEMORAL ALIGNMENT GUIDE; INSTRUMENT

Catalog Number 6541-0-600

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

It was reported that 1 of 2 screws was stuck before use in the medical procedure.Another screw was functional, so skim cut guide could be fixed.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Lot, manufacturing and expiration date updated.An event regarding jammed screw involving a triathlon femoral alignment guide was reported.The event was confirmed.Inspection of the device confirmed the reported event.The damage to the device indicated the device was subject to high torque loads in both the tightening and loosening directions forcing the screw past its normal limits of travel.Material analysis found no evidence of material or manufacturing defects on the surfaces examined.No further information was requested as there is no indication that the event was related to patient factors.A device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.No other events have been reported for the manufacturing lot.The investigation determined the root cause of the jammed screw was related to user misuse, specifically application of high torque loads to the screw when it was at its limit of travel.The surgical protocol indicates a torque limiting screwdriver should be used with this device which would prevent the recurrence of the event.

Event Description

It was reported that 1 of 2 screws was stuck before use in the medical procedure.Another screw was functional, so skim cut guide could be fixed.

• Brand Name: TRIATHLON AR FEMORAL ALIGNMENT GUIDE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3852239
• MDR Text Key: 21806526
• Report Number: 0002249697-2014-02149
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2018
• Device Catalogue Number: 6541-0-600
• Device Lot Number: P7V06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other