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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REAMER PROXIMAL FEM 16E HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US REAMER PROXIMAL FEM 16E HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 534715
Device Problems Dull, Blunt (2407); Material Twisted/Bent (2981); Naturally Worn (2988); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
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 multiple srom reamers were damaged during a surgery with surgeon. The reamers were used to "ream" through some hardware left in a hip. Since the reamers were used to do this, many of them have been damaged and need to be replaced. No further information is available at this time. No surgical delay.

 
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Brand NameREAMER PROXIMAL FEM 16E
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6107428552
MDR Report Key8804595
MDR Text Key151590672
Report Number1818910-2019-98727
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 06/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number534715
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 Received08/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2000
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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