BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIGGER HANDLE F/CABLE CUTTER

    MDR report key: 7526960 · Received May 18, 2018

    Report

    Report Number
    2939274-2018-52223
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Report Date
    April 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    UDI-DI
    10886982076700
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH 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. ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 03.221.006 (SUB COMPONENT 03.221.007 AND 03.221.008) SYNTHES LOT NUMBER: T994177 RELEASE TO WAREHOUSE DATE: 05-DEC-2013 MANUFACTURE SITE: (B)(4). PART EXPIRATION DATE: N/A . LIST OF NONCONFORMANCE¿S: N/A . A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. H3, H6: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: CUSTOMER QUALITY INVESTIGATION: THE FOLLOWING INVESTIGATIONS WERE PERFORMED: DAMAGE (VISUAL APPEARANCE NOT AS EXPECTED): VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED NO BROKEN PORTIONS ON THE RETURNED DEVICE. HOWEVER, THE TENSIONING LEVER WAS RETURNED UNATTACHED TO THE HANDLE PORTION DUE TO THE MISSING CONNECTING SCREW. FURTHERMORE, THE CONNECTING END OF THE HANDLE WAS CONNECTING LIGHTLY LOOSE WHEN ATTEMPTED TO ENGAGE WITH THE BLADE FOR WIRE CUTTER WHICH COULD PROBABLY THE RESULT OF WORN SURFACES. THEREFORE, THE OVERALL COMPLAINT CONDITION WAS CONFIRMED. THE COMPLAINT DESCRIPTION DOES NOT AGREE WITH THE COMPLAINT CONDITION. HOWEVER NEW ISSUES WERE IDENTIFIED AND THEREFORE THE OVERALL COMPLAINT CONDITION WAS CONFIRMED. RELEVANT PRODUCT DRAWINGS WERE REVIEWED: CABLE CUTTER - 03_221_006,03_221_007,03_221_008, AND HANDLE 03_221_007_01 AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION WHEN USED AS RECOMMENDED. DIMENSIONAL CHECK PERFORMED ON THE DIAMETER OF THE HANDLE CONNECTION END MEASURED 12 MM (CA-814) THAT FALLS WITHIN THE SPECIFICATIONS OF 12 MM +/- 0.02 MM PER 03_221_007_01. DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WHILE NO ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE SUCH AS BEING DROPPED OFF DURING USAGE/HANDLING COULD HAVE CONTRIBUTED TO THIS BOTH LOOSE AND MISSING COMPONENT CONDITIONS. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR 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. 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 · 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 · 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: B5: EVENT DESCRIPTION UPDATED. D4: LOT NUMBER. D10: DATE RETURNED TO MANUFACTURER. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. H11 CORRECTED DATA: D4: CATALOG, UDI. 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 A TRIGGER HANDLE FOR THE CABLE CUTTER WAS FOUND BROKEN BY CENTRAL SUPPLY. THERE WAS NO PATIENT INVOLVEMENT. INITIAL INVESTIGATION OF THE RETURNED DEVICE REVEALED THE DOWEL PIN THAT CONNECTS THE TRIGGER TO THE HANDLE IS MISSING.

    Additional Manufacturer Narrative · 1

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, 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 A TRIGGER HANDLE FOR THE CABLE CUTTER WAS FOUND BROKEN BY CENTRAL SUPPLY. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369454 TRIGGER HANDLE F/CABLE CUTTER CUTTER, WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC T994177 10886982076700

    Patients

    Seq Age Sex Outcome Treatment
    1