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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
Model Number 2570-04-500
Device Problems Device-Device Incompatibility (2919); Scratched Material (3020)
Patient Problem Insufficient Information (4580)
Event Date 01/08/2021
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 the broach, neck segment junction are scratched and not fitting properly, angled cup inserter broke off from handle. Reamer shaft is scratched and doesn't fit properly. There was a 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 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11194229
MDR Text Key227582074
Report Number1818910-2021-01437
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
Report Date 01/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/19/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2570-04-500
Device Catalogue Number257004500
Device LOT NumberSO2025663
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/20/2016
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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