MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 49MM HIP INSTRUMENTS : REAMERS

Catalog Number 244000549

Device Problems Dull, Blunt; Material Twisted/Bent

Event Date 02/11/2020

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

Acetabular graters need to be replaced at the surgeons request in multiple sets as they are no longer sharp enough due to normal wear and tear from several primary hip cases. There are also femoral head impactor tips that need to be replaced also due to normal wear and tear. No intra-op or patient issues. No surgical delay.

• Brand Name: QUICKSET ACE GRATER HEAD 49MM
• 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: 9754539
• Report Number: 1818910-2020-06004
• Device Sequence Number: 1
• Product Code: HTO
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/26/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 244000549
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2020
• 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