BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM

    MDR report key: 5471111 · Received March 1, 2016

    Report

    Report Number
    3003875359-2016-10134
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 11, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: ONE (1) INSERTION HANDLE FOR MULTILOC PROXIMAL HUMERAL NAIL (PART 03.019.006 / LOT 8210911) WAS RETURNED WITH A COMPLAINT STATING THAT ONE OF THE PEGS OF THE INSERTION HANDLE HAD BROKEN OFF DURING SURGERY. UPON EVALUATION OF THE RETURNED DEVICE, THE MEDIAL TAB THAT LOCKS IN PLACE INTO THE MULTILOC HUMERAL NAIL WAS BROKEN OFF WITH A LARGER SECTION MISSING ON THE SIDE OF THE ¿LEFT AP¿ ETCH. THE BROKEN TAB WAS NOT RETURNED. THE COMPLAINT IS CONFIRMED. THE INSERTION HANDLE FOR MULTILOC PROXIMAL HUMERAL NAIL IS PART OF THE MULTILOC PROXIMAL HUMERAL NAIL INSTRUMENT SET. WHEN ASSEMBLED INTO AN AIMING ARM CONSTRUCT, THE INSERTION HANDLE ASSISTS IN GUIDING PROXIMAL SCREWS THROUGH THE HUMERAL NAIL. PROPER USE CAN BE FOUND IN THE MULTILOC HUMERAL NAIL TECHNIQUE GUIDE PRODUCT DRAWING. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY RECORD REVIEWS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. FROM THE COMPLAINT DESCRIPTION, IT IS UNCERTAIN IF THE BREAKAGE OCCURRED INTRA-OPERATIVELY, SO A ROOT CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE WHEN TRYING TO ALIGN THE AIMING ARM AND THE NAIL COULD HAVE CAUSED THE DAMAGE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE 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

    ADDITIONAL NARRATIVE: PATIENT INITIALS ¿ (B)(6). PATIENT WEIGHT NOT AVAILABLE FOR REPORTING . DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW - MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 31.JAN.2013. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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 DURING INSERTION OF A HUMERAL NAIL, A QUANTITY OF THREE (3) SCREWS WERE NOT ABLE TO BE LINED UP TO THE NAIL. UPON INSPECTION, IT WAS FOUND THAT ONE OF THE PEGS ON THE INSERTION HANDLE FOR MULTILOC PROXIMAL HUMERAL NAIL WAS MISSING. IT WAS UNKNOWN WHEN THIS PIECE BROKE OFF THE HANDLE AND IT WAS REPORTED THAT NO FRAGMENT WAS GENERATED DURING THE SURGERY. THERE WAS A 30 MINUTE SURGICAL DELAY AS ANOTHER DEVICE WAS NOT READILY AVAILABLE. THE SCREWS WERE ABLE TO BE LINED UP TO THE NAIL USING AN ALTERNATE TECHNIQUE. NO FRAGMENTS WERE GENERATED DURING SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127942 INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES HAGENDORF 8210911

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR