BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 5538964 · Received March 31, 2016

    Report

    Report Number
    9680938-2016-10042
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Report Date
    March 16, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #335119 FOR THE SHAFT 208.0982 / (B)(4) IS CORRESPONDING TO THE SPECIFICATIONS ((B)(4)). ONE NONCONFORMANCE WAS STARTED TO REWORK THE SHAFTS ON THE SPRING MECHANISM DUE TO A DESIGN CHANGE FROM REVISION E TO F. ALL PARTS WERE REWORKED AND INSPECTED 100%. THE REWORK HAS NO BEARING ON THE COMPLAINT ISSUE. THE CTQ FEATURE PIN HEIGHT WAS CHECKED 100% ON 26-MAR-2015. ALL PARTS WERE CHECKED 100% FOR PQP FEATURES AND FOR FUNCTION WITH GUAGE AT THE FINAL INSPECTION ON 10-APR-2015. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE INSTRUMENT DOES NOT SHOW ENOUGH DEFORMATION, NOR SIGNIFICANT DAMAGE THAT WOULD LEAD TO A LOSS OF FUNCTION AS DESCRIBED IN THE COMPLAINT DESCRIPTION. TWO ARTICLES (03.037.017,03.037.024) WERE RETURNED. BOTH ARTICLES SHOW SOME WEAR AND DEFORMATION THAT IS EXPECTED FROM REPEATED USE. THE GUIDE PINS OF THE BLADE IMPACTOR (03.037.024) HAVE SOME SLIGHT DEFORMATION, AND THE PROXIMAL DEPTH STOP ALSO SHOWS SIGNS OF MULTIPLE IMPACTIONS. THE BLADE GUIDE SLEEVE (03.037.17) HAS ONLY MINIMAL WEAR ALONG ITS LENGTH, BUT THE PROXIMAL OPENING OF THE INNER DIAMETER DOES SHOW SOME DEFORMATION, MOST LIKELY CAUSED BY IMPACTION WITH THE BLADE IMPACTOR¿S GUIDE PINS. NEITHER INSTRUMENTS SHOW ENOUGH DEFORMATION, NOR SIGNIFICANT DAMAGE THAT WOULD LEAD TO A LOSS OF FUNCTION AS DESCRIBED IN THE COMPLAINT DESCRIPTION. ADDITIONALLY WHEN THE PARTS WERE TESTED AND THE COMPLAINT EVEN COULD NOT BE REPLICATED, AND NO LOSS IN FUNCTION WAS DETECTED. 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 BLADE/SCREW GUIDE SLEEVE AND THE HELICAL BLADE INSERTER WERE STUCK TOGETHER WHEN ATTEMPTING TO DISASSEMBLE THEM. THIS ISSUE WAS DISCOVERED WHEN TESTING THE TWO DEVICES IN STERILE PROCESSING. THERE WERE NO ISSUES WITH THE DEVICES PRIOR TO THIS DISCOVERY. THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192839 HELICAL BLADE INSERTER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES TUTTLINGEN T118570

    Patients

    Seq Age Sex Outcome Treatment
    1