BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM

    MDR report key: 10486070 · Received September 2, 2020

    Report

    Report Number
    2939274-2020-03936
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Report Date
    July 23, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982069641
    PMA / PMN Number
    EXEMPT
    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. H10 ADDITIONAL NARRATIVE: UPDATED DATA-B5, H11 . 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) FOUND SEVERAL BROKEN ITEMS THAT WERE USED AND DISCOVERED POST-OPERATIVELY. ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER WAS GRINDED AND BROKEN. ONE 2.7/3.5MM DEPTH GAUGE AND ONE (1) SCREWDRIVER FOR 4.5MM TITANIUM MULTILOC SCREWS WERE DAMAGED. NO PROCEDURAL OR PATIENT INFORMATION AVAILABLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J EMPLOYEE. INVESTIGATION SUMMARY: INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM (PART #: 03.019.025, LOT #: L808316) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE CAP COMPONENT HAD BROKEN OFF OF THE PROXIMAL END OF THE LOCKING CORE SHAFT COMPONENT DUE TO BROKEN LASER WELD. THE BROKEN OFF CAP COMPONENT WAS NOT RECEIVED AT US CQ. NO OTHER ISSUES WERE IDENTIFIED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: DRAWING. SPECIFIED DIMENSIONS: SHAFT OD, PROXIMAL END. MEASURED DIMENSIONS: SHAFT OD, PROXIMAL END CONFORMING. DEVICE USED: CALIPER CA802. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DOCUMENT(S) WERE REVIEWED: LOCKING CORE SHAFT: (CURRENT AND MANUFACTURED), CAP: (CURRENT AND MANUFACTURED), LOCKING CORE KPL: (CURRENT AND MANUFACTURED), SCREWDRIVER/ MULTILOC SCREW: (CURRENT AND MANUFACTURED), NO DESIGN ISSUES OR DISCREPANCIES WERE NOTICED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION THE COMPLAINT WAS CONFIRMED AS THE CAP COMPONENT HAD BROKEN OFF OF THE PROXIMAL END OF THE LOCKING CORE SHAFT COMPONENT DUE TO BROKEN LASER WELD. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 LOT: PART: 03.019.025, LOT: L808316, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: JULY 12, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) FOUND SEVERAL BROKEN ITEMS THAT WERE USED IN A CASE THE DAY PRIOR. ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER WAS GRINDED UP AND BROKEN, ONE 2.7/3.5MM DEPTH GAUGE AND ONE (1) SCREWDRIVER FOR 4.5MM TITANIUM MULTILOC SCREWS WERE DAMAGED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR (1) SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950659 SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.019.025 L808316 10886982069641

    Patients

    Seq Age Sex Outcome Treatment
    1 DEPTH GAUGE 2.7/3.5 0-60| DEPTH GAUGE 2.7/3.5 0-60| SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)| SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)