BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM UNIVERSAL DRILL GUIDE

    MDR report key: 9157076 · Received October 4, 2019

    Report

    Report Number
    2939274-2019-61208
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Report Date
    September 13, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982190789
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H10 ADDITIONAL NARRATIVE: H3 (DEVICE EVALUATED BY MFR), H4 (DEVICE MANUFACTURE DATE), H6. THE 2.4 MM UNIVERSAL DRILL GUIDE (P/N: 323.202, LOT#: 4964272) WAS RETURNED AND RECEIVED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DRILL SLEEVE WAS DAMAGED. REST OF THE DEVICE SHOWED NO SIGNS OF DAMAGE OTHER THAN SCRATCHES ON THE RETURNED COMPONENTS WHICH HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS OBSERVED TO BE A MISSING A PIECE. THE REPAIR TECHNICIAN REPORTED THE DRILL SLEEVE WAS DAMAGED DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE 2.4 MM UNIVERSAL DRILL GUIDE (P/N: 323.202, LOT#: 4964272). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE 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. DEVICE HISTORY LOT. PART # 323.202, SYNTHES LOT#: 4964272, SUPPLIER LOT#: NA, RELEASE TO WAREHOUSE DATE: 15 MAR 2005, MANUFACTURED BY SYNTHES: BRANDYWINE, NO NCR'S 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. 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS COMPANY REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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

    IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL (B)(4) SITE ON AN UNKNOWN DATE, THE UNIVERSAL DRILL GUIDE WAS OBSERVED TO BE A MISSING A PIECE. NO PATIENT AND SURGICAL INVOLVEMENT WAS REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.4MM UNIVERSAL DRILL GUIDE. THIS IS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949629 2.4MM UNIVERSAL DRILL GUIDE GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 323.202 4964272 10886982190789

    Patients

    Seq Age Sex Outcome Treatment
    1