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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 PROXIMA MI CALCAR REAMER SMALL HIP INSTRUMENTS : REAMERS

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DEPUY INT'L LTD. 8010379 PROXIMA MI CALCAR REAMER SMALL HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 940080007
Device Problems Device Slipped; Dull, Blunt
Event Date 10/08/2018
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

Couldn't achieve enough traction on the top of the reamer and broach and reamer was blunt.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary the devices were reviewed. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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.

 
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Brand NamePROXIMA MI CALCAR REAMER SMALL
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st. anthony's road
leeds LS11 8 DT
UK  LS11 8 DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw , IN 46582-0988
5743725905
MDR Report Key8005979
Report Number1818910-2018-73534
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number940080007
Device LOT NumberAB3732169
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 Received11/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/06/2017
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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