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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT SZ2/3 TAPERED REAMER HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US SUMMIT SZ2/3 TAPERED REAMER HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257002100
Device Problems Device-Device Incompatibility; Physical Resistance/Sticking
Event Date 02/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Examination of the returned instrument found the reamer to be damaged. 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

Surgeon using our summit reamers and that the 2/3 summit reamer became stuck on the t-handle. After about a 1 minute delay, the reamer was removed and the nurse tested to t-handle on other reamers to determine whether it was the reamer or the t-handle that was causing the issue. The t-handle worked fine on the other reamers and we found that the 2/3 reamer continued to get stuck when testing it after the surgery. There was no patient consequence and there was a 1-minute delay in surgery. Lot # is j1110. Was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> 1, was procedure successfully completed? --> yes, were fragments generated? --> no, patient status/ outcome / consequences --> no.

 
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Brand NameSUMMIT SZ2/3 TAPERED REAMER
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380-0988
6103142063
MDR Report Key8597201
Report Number1818910-2019-93073
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number257002100
Device LOT NumberJ1110
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/03/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2010
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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