BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE

    MDR report key: 8750477 · Received July 1, 2019

    Report

    Report Number
    2939274-2019-58951
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Report Date
    June 4, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587037318
    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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD DEVICE HISTORY LOT PART: 314.411, LOT: L003379, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 26.AUGUST 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: INVESTIGATION SUMMARY EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF A LOANER SET IT WAS OBSERVED THAT THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. FLOW: VISUAL VISUAL INSPECTION: THE PRONGS OF THE HOLDING SLEEVE ARE SLIGHTLY BENT AND MORE SPREAD OUT THAN USUAL. AS NO BROKEN COMPONENTS WERE FOUND, THE COMPLAINT CANNOT BE CONFIRMED. DOCUMENT/ SPECIFICATION REVIEW: SM_103314 REVISION D, SM_103314 REVISION C, 314_411 REVISION M, 314_411_3 REVISION L. PART: 314.411, LOT: L003379, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 26.AUGUST 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS AROUND RETURNED DEVICE COULD NOT BE MEASURED ACCURATELY DUE TO POST MANUFACTURING DAMAGES. INVESTIGATION CONCLUSION: THE EXACT CAUSE OF THE REPORTED CONDITION IS UNKNOWN, BUT IT IS LIKELY DUE TO WEAR FROM REPEATED USE OVER THE LIFETIME OF THE MULTIPLE USE DEVICES. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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 ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS DISCOVERED THAT 314.411, SCREWDRIVER BLADE, LOT NUMBER L003379 WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543301 1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.411 L003379 10887587037318

    Patients

    Seq Age Sex Outcome Treatment
    1