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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT SZ6/7 TAPERED REAMER HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT SZ6/7 TAPERED REAMER HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257002300
Device Problems Difficult to Insert; Material Twisted / Bent; Naturally Worn
Event Date 03/01/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is an instrument and is not implanted/explanted.

 
Event Description

It was reported that during a total hip arthroplasty, the size 6/7 summit tapered reamer was damaged at the top not allowing the reamer to engage with the hudson adapter. There was a 2 minutes surgical delay. It was indicated by the sales rep that there were no pieces broke off during surgery. It seems as though it was stripped at the top where it engaged with the hudson adapter. There were no deficiencies with the hudson adapter on the drill as the other reamers worked.

 
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Brand NameSUMMIT SZ6/7 TAPERED REAMER
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-XXXX
6107428552
MDR Report Key8440887
Report Number1818910-2019-88057
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number257002300
Device LOT NumberSO2016943
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2014
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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