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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 Device-Device Incompatibility (2919); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
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

It was reported that during the case the scrub could not insert the modular calcar planar shaft into the depuy flat chuck. After the case he tried putting it in another chuck and it still didn't work. 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 drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8771035
MDR Text Key150386129
Report Number1818910-2019-97788
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 06/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number257004500
Device LOT NumberSO2026126
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/03/2017
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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