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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 45 DEG ANGLE DRILL DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

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DEPUY ORTHOPAEDICS INC US 45 DEG ANGLE DRILL DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Catalog Number 236683000
Device Problem Difficult to Insert
Event Type  Malfunction  
Manufacturer Narrative

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 instrument found the instrument did not function as intended. 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. Instrument was reported for an unknown reason. Follow ups were made and no additional information was received. A functional check with a mating drill bit found the instruments holding feature to not depress enough to allow the drill bit to be positioned into drill. The root cause is attributed to wear out. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the investigation, the need for corrective action is not indicated. Complaints will be monitored under post market surveillance procedures.

 
Event Description

The office sets instrument was reported for unknown reason. It did not affect surgery or patient. Engineering evaluation: a functional check with a mating drill bit found the instruments holding feature to not depress enough to allow the drill bit to be positioned into drill.

 
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Brand Name45 DEG ANGLE DRILL
Type of DeviceDRILLS (BITS, SLEEVES, GUIDES) : DRILLS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key8425617
Report Number1818910-2019-87466
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 02/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number236683000
Device LOT NumberSO2005126
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/30/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2012
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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