BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    . CROSS PINNED HEX SCREWDRIVER . SHAFT/QC

    MDR report key: 11867125 · Received May 21, 2021

    Report

    Report Number
    8030965-2021-04154
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 26, 2021
    Report Date
    April 26, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819310612
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6: PART: 03.614.039 SYNTHES LOT: 5892649 SUPPLIER LOT: IS10061 RELEASE TO WAREHOUSE DATE: OCTOBER 03, 2008 SUPPLIER: ISIMAC MACHINE COMPANY NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED HAVE SLIGHT SCRATCHES ON THE DEVICES AND NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED DUE TO ALLEGED COMPLAINT CONDITION. THE FUNCTIONAL TEST WAS PERFORMED WITH THE RECEIVED MATING DEVICE HOLD-SL THE DEVICE WAS ABLE TO ASSEMBLE AND FUNCTIONING AS INTENDED. THE OBSERVED UNABLE TO ASSEMBLE CONDITION OF THE COMPONENTS IS NOT CONSISTENT WITH THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR HEXAGONAL SCREWDRIVER SHAFT CROSS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. *********************************************** DRAWING/SPECIFICATIONS REVIEWED THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED: -2.4MM HEX INSERTION SCREW DRIVER SHAFT ASSY DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. B5 D9 G1

    Description of Event or Problem · 0

    THIS IS REPORT 1 OF 2 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON WAS NOT ABLE TO CONNECT THE SCREWDRIVER TO A SCREW. ALSO, RATCHET MOVEMENT ON THE RATCHET HANDLE BECAME AWKWARD. THE SURGERY COMPLETED WITH 30 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1) CROSS PINNED HEX SCREWDRIVER SHAFT/QC. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762850 . CROSS PINNED HEX SCREWDRIVER . SHAFT/QC SCREWDRIVERS HXX SYNTHES GMBH IS10061 07611819310612

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDLE W/RATCHET WRENCH F/QC SM| HOLD-SL| UNK - SCREWS