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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 52MM HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2440-00-552
Device Problems Dull, Blunt; Failure to Cut
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.

 
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Brand NameQUICKSET ACE GRATER HEAD 52MM
Type of DeviceHIP 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 Key9738917
Report Number1818910-2020-05461
Device Sequence Number1
Product CodeHTO
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 Received02/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2440-00-552
Device Catalogue Number244000552
Device LOT NumberSO2010195
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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