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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT S4/5 TAPERED REAMER HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT S4/5 TAPERED REAMER HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257002200
Device Problems Connection Problem; Material Twisted / Bent
Event Date 01/14/2019
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.

 
Event Description

It was reported that the connection end of the 4-5 summit straight reamer is damaged and will not fit into the power quick connect. No surgical delay.

 
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Brand NameSUMMIT S4/5 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 19380-0988
6103142063
MDR Report Key8337168
Report Number1818910-2019-84468
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number257002200
Device LOT NumberSO2010073
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2013
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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