MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 61MM HIP INSTRUMENTS : REAMERS

Catalog Number 244000561

Device Problems Dull, Blunt; Failure to Cut

Event Date 01/27/2020

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

The acetabular reamers need to be replaced because they are getting very dull.

• Brand Name: QUICKSET ACE GRATER HEAD 61MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw , IN 46581-0988 ; 6107428552
• MDR Report Key: 9738465
• Report Number: 1818910-2020-05574
• Device Sequence Number: 1
• Product Code: HTO
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/21/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 244000561
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown