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

Model Number	96-6683
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 as the instruments were being assembled before the case, it was noticed that the patellar reamer body would not accept the pin and blade for the planer (pin would not seat).In the same tray, the patellar clamp handle would not hold the patellar clamp tightly as it would not lock into place.

• 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 46581 0988
• MDR Report Key: 11217658
• Report Number: 1818910-2021-01718
• Device Sequence Number: 19725614
• Product Code: HXD
• UDI-Device Identifier: 10603295249610
• UDI-Public: 10603295249610
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: 96-6683
• Device Catalogue Number: 966683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1