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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE HIP INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 244000510
Device Problems Material Discolored (1170); Pitted (1460); Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2018
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). This report is a duplicate report for manufacturer report number 1818910-2018-78867 which was submitted on 12/20/2018. At this time we have not received successful passed acknowledgments for that report number so this report is being submitted to ensure successful receipt of the information. 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.

 
Event Description

It was reported that quickset reamer handles are worn and need to be replaced per request from facility. No surgical delay.

 
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Brand NameQUICKSET ACE GRATER HANDLE
Type of DeviceHIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6103142063
MDR Report Key8190155
MDR Text Key131177667
Report Number1818910-2018-79017
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
Type of Report Initial
Report Date 11/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000510
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2010
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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