BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 10580958 · Received September 24, 2020

    Report

    Report Number
    2939274-2020-04308
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Report Date
    September 1, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6 INVESTIGATION SUMMARY: VISUAL INSPECTION: THE SHAFT (P/N: 03.505.003, LOT NUMBER: 8180518) WAS RECEIVED AT US CQ. THE VISUAL INSPECTION OF THE COMPLIANT DEVICE INDICATED THAT THE GEAR AND COVER COMPONENTS WERE FELL APART FROM THE SHAFT HEAD COMPONENT. NO OTHER DAMAGES WERE OBSERVED ON THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: (CURRENT AND MANUFACTURED) WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS IRRELEVANT TO THE COMPLAINT CONDITION. COMPLAINT CONFIRMED? NO. THE ALLEGED STRIPPED CONDITION WAS NOT CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS NOT CONFIRMED AS THE STRIPPED CONDITION WAS NOT OBSERVED ON THE RETURNED DEVICE. THE GEAR AND COVER COMPONENTS WERE FELL APART FROM THE SHAFT HEAD COMPONENT.. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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: PART: 03.505.003; LOT: 8180518; MANUFACTURING SITE: SELZACH; SUPPLIER: (B)(4); RELEASE TO WAREHOUSE DATE: 28. SEPT. 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    ADDITIONAL PRODUCT CODE DZI, DZJ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. 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 (B)(6) 2020, THE MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIX RIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER CHECK ON INVENTORY ITEMS IN A TERRITORY WITH UNKNOWN ALLEGATIONS. THE HANDLE FOR 90° SCREWDRIVER WOULD STRIP OUT/NOT TURN SCREW WHEN TESTED. THE SHAFT FOR 90° SCREWDRIVER WOULD STRIP OUT/NOT TURN SCREW WHEN TESTED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-FIVE (25) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90° SCREWDRIVER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045218 SHAFT FOR 90 SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.003 8180518 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1