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

Catalog Number 961673

Device Problems Disassembly (1168); Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the inspection of the returned devices, the orthokit technician noticed that the sealing joint of the instrument ref (b)(4) was missing and there are brown colour stains on the instrument.

Manufacturer Narrative

Examination of the returned device confirmed the black plastic protector component is cracked.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.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: 5751925
• MDR Text Key: 48300667
• Report Number: 1818910-2016-22238
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• 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: SO2012917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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