MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SLEEVE TRIALS

Catalog Number UNK SLEEVE TRIALS

Device Problem Scratched Material (3020)

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

Event Date 11/25/2020

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 instruments are scraped and damage from prolonged use.No surgical delay.

Manufacturer Narrative

Com-(b)(4).

• Brand Name: UNKNOWN SLEEVE TRIALS
• Type of Device: SLEEVE TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10969402
• MDR Text Key: 221248245
• Report Number: 1818910-2020-26494
• Device Sequence Number: 1
• Product Code: NJL
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SLEEVE TRIALS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1