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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL CALCAR REAMER SMALL HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US CORAIL CALCAR REAMER SMALL HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number L94009
Device Problems Dull, Blunt; Failure to Cut
Event Date 02/01/2020
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

Calcar remeamer is dull.

 
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Brand NameCORAIL CALCAR REAMER SMALL
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
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9757164
Report Number1818910-2020-06052
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 02/05/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberL94009
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? Yes
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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