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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 53MM HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 53MM HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000553
Device Problems Dull, Blunt; Scratched Material
Event Date 04/01/2019
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 reamer shells are dull.

 
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Brand NameQUICKSET ACE GRATER HEAD 53MM
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
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key8609898
Report Number1818910-2019-93486
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 04/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number244000553
Device LOT NumberA0910
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2010
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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