MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 52MM HIP INSTRUMENTS : REAMERS

Model Number 2440-00-552

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem Not Applicable (3189)

Event Date 01/30/2020

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

They have in consignment 9 stem instrument sets and 6 acetabular instr sets, as they have been waiting for 3 more new acetabular instr sets since (b)(6) 2019. In the meantime, we have left 2 sets of acetabular instruments from oc in order to cover those busy days. They opened those 2 loaners yesterday, and for both of them,the surgeons just could not do the reaming as they said the reamers were totally dull. They had to open zimmer acetabular instruments to finish their surgeries.

• Brand Name: QUICKSET ACE GRATER HEAD 52MM
• 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: 9738917
• MDR Text Key: 190360266
• Report Number: 1818910-2020-05461
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

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 MODEL Number: 2440-00-552
• Device Catalogue Number: 244000552
• Device LOT Number: SO2010195
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/10/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/03/2013
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown