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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 GLEN MANUAL REAMER D42 MM EXTREMITY INSTRUMENTS : REAMERS

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DEPUY FRANCE SAS - 3003895575 GLEN MANUAL REAMER D42 MM EXTREMITY INSTRUMENTS : REAMERS Back to Search Results
Model Number 2307-88-242
Device Problems Dull, Blunt; Failure to Cut; Material Twisted/Bent
Event Date 02/03/2020
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. Investigation summary: examination of the returned device confirmed the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Event Description

It was reported that the instrument was dull from common wear and tear. No surgical delay.

 
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Brand NameGLEN MANUAL REAMER D42 MM
Type of DeviceEXTREMITY INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 46581-0988
6107428552
MDR Report Key9745637
Report Number1818910-2020-05756
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2307-88-242
Device Catalogue Number230788242
Device LOT Number5077968
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2011
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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