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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 QUICKSET 1PC FLEX DRILL BIT 35 DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

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DEPUY ORTHOPAEDICS INC US 1818910 QUICKSET 1PC FLEX DRILL BIT 35 DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Catalog Number 227435500
Device Problem Unraveled Material
Event Date 10/11/2018
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.

 
Event Description

Unraveled on the shafts.

 
Manufacturer Narrative

Product complaint # pc-(b)(4). Investigation summary examination of the returned instrument confirmed the complaint. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameQUICKSET 1PC FLEX DRILL BIT 35
Type of DeviceDRILLS (BITS, SLEEVES, GUIDES) : DRILLS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key8028171
Report Number1818910-2018-74170
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number227435500
Device LOT NumberPG235899
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2013
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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