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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 LOCKING SCREWDRIVER ROD; EXTREMITY INSTRUMENTS : SCREWDRIVERS
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DEPUY FRANCE SAS - 3003895575 LOCKING SCREWDRIVER ROD; EXTREMITY INSTRUMENTS : SCREWDRIVERS Back to Search Results
Catalog Number 230792004
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/06/2018
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
It was reported that the yellow screwdriver would not engage at the top and the long skinny green screwdriver had the plastic handle dislodged forward.
 
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.
 
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Brand Name
LOCKING SCREWDRIVER ROD
Common Device Name
EXTREMITY INSTRUMENTS : SCREWDRIVERS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key8083884
Report Number1818910-2018-75864
Device Sequence Number11167754
Product Code HXX
UDI-Device Identifier10603295116578
UDI-Public10603295116578
Combination Product (Y/N)N
Initial Reporter StateCO
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,Followup
Report Date (Section B) 11/06/2018
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 Number230792004
Device Lot Number5002529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2018
Initial Date Received by Manufacturer 11/06/2018
Supplement Date Received by Manufacturer11/29/2018
Initial Report FDA Received Date11/19/2018
Supplement Report FDA Received Date12/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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