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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 57MM HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 57MM HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000557
Device Problem Material Erosion
Event Date 10/24/2018
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

Instrument is rusty.

 
Manufacturer Narrative

(b)(4). Investigation summary:the instrument associated with this report was not returned. Depuy considers the investigation closed at this time. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameQUICKSET ACE GRATER HEAD 57MM
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-XXXX
6103142063
MDR Report Key8071048
Report Number1818910-2018-75506
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000557
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
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 Initial

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