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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  QUICKSET 1PC FLEX DRILL BIT 25 DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

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DEPUY ORTHOPAEDICS, INC. 1818910  QUICKSET 1PC FLEX DRILL BIT 25 DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Catalog Number 227425500
Device Problem Unraveled Material
Event Date 11/01/2018
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

It was reported that the flex/spring portion of 25mm pinn flex drill bit is starting to unravel.

 
Manufacturer Narrative

Product complaint (b)(4). Investigation summary the instrument associated with this report was not returned. 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, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: the instrument associated with this report was not returned. 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. Reopened - product received. 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 25
Type of DeviceDRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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
6103142063
MDR Report Key8086629
Report Number1818910-2018-75958
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number227425500
Device LOT NumberPG270762
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/20/2017
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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