MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIG FEM ADPT TORQUE WRENCH; KNEE INSTRUMENT/TRIAL

Catalog Number 961673

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The instrument is missing a screw and won't function properly.

Manufacturer Narrative

Conclusion and justification status for mdr: examination of the returned device found the black plastic protector component has broke and spins on the wrench.The root cause is attributed to product design.(b)(4) has been initiated to remove the radel® socket cap altogether and replace with a teflon® (ptfe ¿ polytetrafluoroethylene) split ring and a peek (polyetheretherketone) disc to the torque wrench.The current complaint sample product was manufactured prior to the implementation of (b)(4).No further corrective action required.Examination of the returned device confirmed the missing screws and disassembled scale.The screws and the scale were not returned.The root cause of the missing screws and scale is unknown.No conclusions could be drawn without the screws to examine.Based on the inability to determine a root cause, a need for corrective action is not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SIG FEM ADPT TORQUE WRENCH
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5949466
• MDR Text Key: 54677817
• Report Number: 1818910-2016-27153
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 961673
• Device Lot Number: A0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1