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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 4.0MM FEMALE HEX DRIVER; EXTREMITY INSTRUMENTS : SCREWDRIVERS
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DEPUY IRELAND - 9616671 4.0MM FEMALE HEX DRIVER; EXTREMITY INSTRUMENTS : SCREWDRIVERS Back to Search Results
Catalog Number 210070155
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/31/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.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
Screwdriver cracked when tightening proximal body to distal stem.
 
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Brand Name
4.0MM FEMALE HEX DRIVER
Common Device Name
EXTREMITY INSTRUMENTS : SCREWDRIVERS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
MDR Report Key8267327
Report Number1818910-2019-81774
Device Sequence Number11294332
Product Code HXX
UDI-Device Identifier10603295085959
UDI-Public10603295085959
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/31/2018
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 Number210070155
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/31/2018
Supplement Date Received by Manufacturer12/31/2018
Initial Report FDA Received Date01/22/2019
Supplement Report FDA Received Date01/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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