MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRL,SZ2.5; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number 96-1048

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/02/2020

Event Type  malfunction  

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 Description

It was reported that the screwdriver and box trial are stripped.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the submitted device confirmed the reported the screw was stripped.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Type of Device: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10540571
• MDR Text Key: 207142383
• Report Number: 1818910-2020-20183
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295234760
• UDI-Public: 10603295234760
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 96-1048
• Device Catalogue Number: 961048
• Device Lot Number: J0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR