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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DIST REAMER EXTENSION RECLAIM INSTRUMENTS : ADAPTORS

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DEPUY IRELAND - 9616671 RECLAIM DIST REAMER EXTENSION RECLAIM INSTRUMENTS : ADAPTORS Back to Search Results
Model Number 2975-00-500
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
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 the spring will not hold the white poly handle in place. No surgical delay.

 
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Brand NameRECLAIM DIST REAMER EXTENSION
Type of DeviceRECLAIM INSTRUMENTS : ADAPTORS
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
1210 ward avenue
west chester, PA 46581-0988
6103142063
MDR Report Key9557496
MDR Text Key188893082
Report Number1818910-2020-00768
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
Report Date 12/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2975-00-500
Device Catalogue Number297500500
Device LOT NumberNB88429
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2014
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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