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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 Deformation; Naturally Worn; Scratched Material
Event Date 04/12/2019
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 plannar was stripped.

 
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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 drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key8571407
Report Number1818910-2019-92224
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2019
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 Manufacturer04/22/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
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?
Type of Device Usage Unkown

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