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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MI CALCAR REAMER SHAFT HIP INSTRUMENTS : REAMERS

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DEPUY IRELAND - 9616671 MI CALCAR REAMER SHAFT HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257004500
Device Problems Material Twisted/Bent; Scratched Material
Event Date 05/16/2019
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

It was reported that the calcar planer shaft got caught on broach stripping the metal on both tips. Broach no longer connects to the handle properly. No surgical delay.

 
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Brand NameMI CALCAR REAMER SHAFT
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380-0988
6103142063
MDR Report Key8667756
Report Number1818910-2019-95195
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number257004500
Device LOT NumberSO2037282
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2018
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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