MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG HP FIXED REF AP BLK SZ1.5; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 9505-02-152

Device Problem Material Deformation (2976)

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

Event Date 09/22/2020

Event Type  malfunction  

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 Description

It was reported that the surgeon was unable to place a drill pin through the +2 posterior referencing drill hole as the metal surrounding the drill hole has become warped due to repeated use.The metal was blocking the drill pin from going through the drill hole.No surgical delay.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event of deformation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SIG HP FIXED REF AP BLK SZ1.5
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10639121
• MDR Text Key: 210180787
• Report Number: 1818910-2020-21674
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295228516
• UDI-Public: 10603295228516
• 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,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-02-152
• Device Catalogue Number: 950502152
• Device Lot Number: J0508J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1