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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 APG+ STRAIGHT HANDLE OUTER; EXTREMITY INSTRUMENTS : SCREWDRIVERS
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DEPUY ORTHOPAEDICS, INC. 1818910 APG+ STRAIGHT HANDLE OUTER; EXTREMITY INSTRUMENTS : SCREWDRIVERS Back to Search Results
Catalog Number 223000025
Medical Device Problem Codes Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/19/2018
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
Sizing and fit issue.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.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.
 
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Brand Name
APG+ STRAIGHT HANDLE OUTER
Common Device Name
EXTREMITY INSTRUMENTS : SCREWDRIVERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8160476
Report Number1818910-2018-78076
Device Sequence Number2203000
Product Code LXH
UDI-Device Identifier10603295102984
UDI-Public10603295102984
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) 11/19/2018
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 Number223000025
Device Lot NumberFF1MV4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Initial Date Received by Manufacturer 11/19/2018
Supplement Date Received by Manufacturer12/18/2018
Initial Report FDA Received Date12/13/2018
Supplement Report FDA Received Date12/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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