BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDING TEMPLATE 22 HOLES F/ 3.5MM CURVED RECON PLATES

    MDR report key: 11396562 · Received March 1, 2021

    Report

    Report Number
    2939274-2021-01110
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Report Date
    February 5, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWT
    UDI-DI
    10886982192141
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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: INVESTIGATION SUMMARY VISUAL INSPECTION: BENDING TEMPLATE 22 HOLES F/ 3.5MM CURVED RECON PLATES (PART# 329.66, LOT# L130901, QTY# 1) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE TEMPLATE GOT BROKEN INTO MULTIPLE PIECES. ALL BROKEN PIECES WERE NOT RETURNED AT CQ. REST OF THE SURFACE OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THUS, THE COMPLAINT IS BEING CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED? YES DIMENSIONAL INSPECTION (CALIPERS: CA215P): DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE THICKNESS OF THE BENDING TEMPLATE WAS MEASURED TO BE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR BENDING TEMPLATE 22 HOLES F/ 3.5MM CURVED RECON PLATES (PART# 329.66, LOT# L130901) AS THE TEMPLATE GOT BROKEN INTO MULTIPLE PIECES. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM, IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. 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 UPON THESE RESULTS, 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: 329.660 LOT: L130901 MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: SEPTEMBER 29, 2016 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. CORRECTED DATA: H3, H6.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN 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 THE BENDING PLATES WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) BENDING TEMPLATE 22 HOLES F/ 3.5MM CURVED RECON PLATES. THIS IS REPORT 7 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290069 BENDING TEMPLATE 22 HOLES F/ 3.5MM CURVED RECON PLATES TEMPLATE HWT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 329.66 L130901 10886982192141

    Patients

    Seq Age Sex Outcome Treatment
    1