BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL BLADE 5MM

    MDR report key: 8096701 · Received November 21, 2018

    Report

    Report Number
    2939274-2018-55077
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Report Date
    November 5, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZO
    UDI-DI
    10886982202963
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 399.580, LOT: T170903. MANUFACTURING LOCATION: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: SEP 04, 2018. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED RAW MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. NO NON CONFORMANCE REPORTS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. REVIEW OF THE DEVICE HISTORY RECORD OF TUTTLINGEN SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. PRODUCT INVESTIGATION WAS COMPLETED. THE CHISEL BLADE W/5 (399.580) WAS RECEIVED BROKEN, WITH A FRAGMENT MISSING FROM A CORNER OF THE DISTAL CUTTING EDGE; THE FRAGMENT WAS NOT RETURNED. ADDITIONAL SURFACE WEAR CONSISTENT WITH USE WAS NOTED WHICH WOULD NOT IMPACT DEVICE FUNCTIONALITY. THE RECEIVED DEVICE MATCHES THE REPORTED CONDITION OF BROKEN, AS SUCH THE COMPLAINT IS CONFIRMED. THE DEVICE WAS DISCOVERED BROKEN, AS SUCH THE SPECIFIC CIRCUMSTANCES AT THE TIME OF THE ISSUE ARE UNKNOWN, THEREFORE, IT CANNOT BE DEFINITIVELY DETERMINED IF EXTERNAL FACTORS (USE ERROR, MISUSE/ABUSE, ETC.) IMPACTED THE COMPLAINT CONDITION. INSPECTION OF THE RELEVANT FEATURE, THE CUTTING EDGE, WAS UNABLE TO BE COMPLETED DUE TO POST MANUFACTURING DAMAGE. RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISIONS, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE CHISEL BLADE WAS FOUND TO BE BROKEN. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION IS RELATED TO SURGICAL TECHNIQUE AND/OR MISUSE. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    REPORTER IS SYNTHES SALES CONSULTANT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 ON AN UNKNOWN DATE, A CURVED CHISEL BLADE BROKE. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CHISEL BLADE 5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934001 CHISEL BLADE 5MM CHISEL, SURGICAL INSTRUMENT FZO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.58 T170903 10886982202963

    Patients

    Seq Age Sex Outcome Treatment
    1