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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN REV PERIPH DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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DEPUY ORTHOPAEDICS INC US PIN REV PERIPH DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Catalog Number 227481000
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 10/26/2018
Type of Reportable Event Malfunction
Additional 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 or Problem Description
The drill bit broke.
 
Additional 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, will be filed as appropriate.
 
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Brand Name
PIN REV PERIPH DRILL
Common Device Name
DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8075631
Report Number1818910-2018-75693
Device Sequence Number11328130
Product Code HTW
UDI-Device Identifier10603295109433
UDI-Public10603295109433
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number227481000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/26/2018
Supplement Date Received by Manufacturer11/28/2018
Initial Report FDA Received Date11/15/2018
Supplement Report FDA Received Date11/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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