MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 7 DEG KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 2492-56-000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

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 all these instruments are worn down from many years of frequent use.

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary : examination of the returned device confirmed the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s). Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

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.

• Brand Name: TIBIAL RESECTION BLOCK 7 DEG
• 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: 11297793
• Report Number: 1818910-2021-02647
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295126003
• UDI-Public: 10603295126003
• 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,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2492-56-000
• Device Catalogue Number: 249256000
• Device Lot Number: AH1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No