BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 7819169 · Received August 27, 2018

    Report

    Report Number
    2939274-2018-53483
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Report Date
    August 8, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDQ
    UDI-DI
    10887587010847
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.501.080, LOT# 9812895. MANUFACTURING LOCATION: HAEGENDORF, RELEASE TO WAREHOUSE DATE: FEB 05, 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: PRODUCT INVESTIGATION WAS COMPLETED. THE CUSTOMER REPORTED THE ZIPFIX TRIGGER WOULD NOT PULL BACK WHEN THE CUTTER WAS ENGAGED. THE REPAIR TECHNICIAN REPORTED THE CUTTING ARM AND CUTTING LEVER TABS WERE BENT. BENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. THE ZIPFIX APPLICATOR WAS RECEIVED WITH BENT CUTTING LEVER TABS AS WELL AS A BENT CUTTING ARM, AS DESCRIBED AT SERVICE AND REPAIR. DUE TO THE POST-MANUFACTURING BENDING THE DEVICE DOES NOT FUNCTION. WHEN PRESSURE IS APPLIED TO THE TRIGGER HANDLE THE DEVICE CANNOT CYCLE THROUGH THE CUTTING MOTIONS AS INTENDED. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AND THE COMPLAINT WAS ABLE TO BE REPLICATED, THEREFORE THE COMPLAINT IS CONFIRMED. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT FEATURES ARE SIGNIFICANTLY DEFORMED. RELEVANT DRAWINGS WERE REVIEWED. THE COMPLAINT CONDITION IS CONFIRMED AS THE ZIPFIX APPLICATOR WAS RECEIVED BENT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES THROUGH MISUSE OR STERILE PROCESSING. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE MALFUNCTIONED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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) 2018, THE APPLICATION INSTRUMENT FOR THE STERNAL ZIPFIX WOULD NOT ALLOW THE TRIGGER TO PULL BACK WHEN THE CUTTER WAS ENGAGED. THE ISSUE WAS DISCOVERED IN CENTRAL STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.  THIS REPORT IS FOR ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660514 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.501.080 9812895 10887587010847

    Patients

    Seq Age Sex Outcome Treatment
    1