MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 AP CHAMF BLK POPUP R.H.SZ4 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 96-6144

Device Problem Material Deformation (2976)

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

Event Date 12/09/2020

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 one of the spikes on the back of the specialist two size 4 femoral cutting block is bent due to excessive use. No pieces broke off and a replacement is needed. No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary : examination of the reported event confirmed the reported damage. The investigation did not establish that a broader investigation or corrective action was necessary. Depuy 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. 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.

• Brand Name: SP2 AP CHAMF BLK POPUP R.H.SZ4
• 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: 11058394
• Report Number: 1818910-2020-27593
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295246992
• UDI-Public: 10603295246992
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 96-6144
• Device Catalogue Number: 966144
• Device Lot Number: B0705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No