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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROXIMAL REAMER 20MM RECLAIM INSTRUMENTS : REAMERS

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DEPUY IRELAND - 9616671 RECLAIM PROXIMAL REAMER 20MM RECLAIM INSTRUMENTS : REAMERS Back to Search Results
Model Number 2975-20-105
Device Problems Break (1069); Corroded (1131); Material Discolored (1170); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2017
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). Non-health care professional. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary : examination of the returned instrument confirmed the complaint. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Event Description

After receiving 2 complaints about a hip kit orthokit manager checked the build 5 in the warehouse, and saw rust on almost every part of the kit. For some parts it's also missing color codes (usually red, yellow, green, blue). This kit went to a customer in (b)(6) 2016 and was new at the time. It was checked when it came back in 2016 and was let in storage since then.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameRECLAIM PROXIMAL REAMER 20MM
Type of DeviceRECLAIM 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
700 orthopaedic dr.
warsaw, IN 46582-0988
6103142063
MDR Report Key7850183
MDR Text Key119340223
Report Number1818910-2018-68525
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2975-20-105
Device Catalogue Number297520105
Device LOT NumberA0311
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2011
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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