BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM

    MDR report key: 3691872 · Received March 21, 2014

    Report

    Report Number
    3003875359-2014-10040
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE RECEIVED DEVICES (03.019.012, 03.019.008, 03.019.006) ARE CRITICAL COMPONENTS OF THE SYNTHES MULTILOC HUMERAL NAIL SYSTEM AND PROVIDE COMPREHENSIVE TREATMENT OF HUMERAL FRACTURES. THE AIMING ARMS AND INSERTION HANDLE ARE IN EXCELLENT CONDITION ALTHOUGH MANUFACTURED 12/12, 12/11 & 2/13 RESPECTIVELY, AND SHOW MINIMAL WEAR FROM USE. THESE DEVICES WERE ASSEMBLED WITH THEIR MATING PARTS TO REPLICATE THE RECOMMENDED CONSTRUCT FOR USE. THE RELATED DEVICES USED FOR THIS EVALUATION ARE: 03.019.013 LOT# 3496545/ 13.0MM/10.0MM PROTECTION SLEEVE FOR 4.5MM TI MULTILOC SCREWS, 150MM; 03.010.063 LOT# 1485271/ 12.0MM/8MM PROTECTION SLEEVE, 188MM; 03.010.064 LOT# 4712912/ 8.0MM/3.2MM DRILL SLEEVE, 200MM; 03.019.014 LOT# 3570195/ 10.0MM/3.8MM DRILL SLEEVE FOR 03.019.013; 04.016.034 LOT# 5911215/ 8MM X 160MM MULTILOC PROXIMAL HUMERAL NAIL; 04.017.195 LOT# 5916878/ 7MM X 195MM MULTILOC NAIL; 03.010.060 LOT#31851 / 32.MM THREE FLUTED DRILL BIT, QUICK COUPLING, 330MM, 100MM CALIBRATION; 03.019.016 LOT#U126865/ 3.8MM THREE FLUTED DRILL BIT, QUICK COUPLING, CALIBRATED, 270MM. THE ASSEMBLY OF THE RECOMMENDED CONSTRUCTS USING THE ABOVE COMMENCED AND FOCUSED ON THE MULTIPLE POTENTIAL ALIGNMENT POSITIONS IN RELATIONSHIP TO THE TARGETED NAIL HOLES OF THE HUMERAL NAIL SAMPLES WAS EVALUATED. IT WAS LEARNED THAT EACH POTENTIAL TARGETING POSITION OF THE CONSTRUCT ACCURATELY ALIGNED WITH THE INTENDED NAIL HOLES IN BOTH AIMING ARM SAMPLES AND IN BOTH LEFT AND RIGHT APPLICATIONS USING THE RETURNED INSERTION HANDLE. AFTER REPEATED TESTING OF THE SAME, NO ALIGNMENT ISSUE OF ANY KIND WAS DETECTED AND THEREFORE, THE COMPLAINT CONDITION COULD NOT BE REPLICATED AND LIKELY THE METHOD OF USE FOR THESE DEVICES HAS LED TO THIS COMPLAINT. DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY FOR THESE DEVICES. THESE DEVICES ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE AND THE COMPLAINT IS UNCONFIRMED. 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 AFTER THE SURGEON WAS IMPLANTING A MULTILOC PROXIMAL HUMERAL NAIL AND INSERTING THE NAIL, HE ATTEMPTED TO PUT THE SCREWS THROUGH THE NAIL, BUT THEY WERE NOT LINING UP CORRECTLY AND THEY WERE HITTING THE NAIL. THIS IS REPORT 3 OF 3 OF COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170415 INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES HAGENDORF 8296797

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR