MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRIAL SZ5; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	96-1045
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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
The screw, which allows to maintain the test block, does not have a stopper as usual.Once the screw goes out, it was impossible to replace it.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed the set screw were disassembled from the trial.All parts were found to be within print specification.Therefore, a manufacturing issue is not suspected.No further escalation is deemed necessary at this time.Depuy synthes 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.

• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10414837
• Report Number: 1818910-2020-18246
• Device Sequence Number: 16844841
• Product Code: LXH
• UDI-Device Identifier: 10603295234739
• UDI-Public: 10603295234739
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2020

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: 96-1045
• Device Catalogue Number: 961045
• Device Lot Number: SO2045192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 04/08/2021
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/15/2020; 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1