MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA INSET PATELLA CLAMP HEAD; KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS

Catalog Number	966683
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when cementing patella, the tip on the clamp which rests on the articular surface of patella kept slipping, making it difficult to add adequate pressure.Rubber ring looks worn.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA INSET PATELLA CLAMP HEAD
• Common Device Name: KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7424588
• Report Number: 1818910-2018-57186
• Device Sequence Number: 1607682
• Product Code: HXD
• UDI-Device Identifier: 10603295249610
• UDI-Public: 10603295249610
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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 Catalogue Number: 966683
• Device Lot Number: H0306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR