MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG FEM ADPT TORQUE WRENCH; KNEE INSTRUMENT : TORQUE DEVICES

Model Number	96-1673
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the outer black plastic cover on the distal torque mount was missing and the inner white plastic was cracked.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device was received for examination.Therefore, the reported event could not be confirmed.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG FEM ADPT TORQUE WRENCH
• Common Device Name: KNEE INSTRUMENT : TORQUE DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14052588
• Report Number: 1818910-2022-06406
• Device Sequence Number: 4987248
• Product Code: HXC
• UDI-Device Identifier: 10603295239789
• UDI-Public: 10603295239789
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 96-1673
• Device Catalogue Number: 961673
• Device Lot Number: SO2032323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown