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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM TPD HEX DRIVER; HIP INSTRUMENTS : SCREWDRIVERS
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DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM TPD HEX DRIVER; HIP INSTRUMENTS : SCREWDRIVERS Back to Search Results
Catalog Number 234601000
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint : (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.
 
Event or Problem Description
It was reported that the screw driver is stripped.
 
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Brand Name
APEX HOLE ELIM TPD HEX DRIVER
Common Device Name
HIP INSTRUMENTS : SCREWDRIVERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8245038
Report Number1818910-2019-80813
Device Sequence Number2126862
Product Code HXX
UDI-Device Identifier10603295119715
UDI-Public10603295119715
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number234601000
Device Lot NumberAG0409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/18/2018
Initial Report FDA Received Date01/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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