BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS

    MDR report key: 8276287 · Received January 24, 2019

    Report

    Report Number
    0009610622-2019-00056
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    November 28, 2018
    Report Date
    April 2, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540196330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION REVEALED THE COMPRESSION SCREW DRIVER HAD BROKEN IN THE PRE-DETERMINED BREAKING POINT. ADDITIONALLY, THE HEXAGON HAD BROKEN, AS WELL. THE REVIEW OF MANUFACTURING DOCUMENTS REVEALED NO DEFICIENCY IN MANUFACTURING. HARDNESS TESTS REVEALED NO DEFICIENCY IN MATERIAL. DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS. A REVIEW OF THE FMEA REVEALED THAT INSTRUMENT BREAKAGE HAD BEEN CONSIDERED. EVALUATION RESULTS DID NOT INDICATE A NON-CONFORMITY, ADVERSE TREND OR UNANTICIPATED HAZARD. NO FURTHER ACTION IS REQUIRED AT THIS TIME. FOUND EVIDENCES IDENTIFIED ¿ MATERIAL ORIENTATION AT THE PRE-DETERMINED BREAKING POINT ¿ THAT THE SCREWDRIVER HAD BEEN OPERATED IN RIGHT (CLOCK-WISE) DIRECTION WHEN SEPARATED. FOUND EVIDENCES IDENTIFIED ¿ MATERIAL ORIENTATION AT THE HEXAGON ¿ THAT THE SCREWDRIVER HAD BEEN OPERATED IN RIGHT (CLOCK-WISE) DIRECTION WHEN SEPARATED. BOTH EVIDENCES IDENTIFY THE SCREWDRIVER BROKE DUE TO INCREASED OVERLOAD DURING TIGHTENING PROCEDURE. THE OPERATIVE TECHNIQUE FOR THE HUMERAL NAILING SYSTEM INSTRUCTS: ¿¿ THE COMPRESSION SCREW IS GENTLY TIGHTENED UTILIZING THE TWO-FINGER TECHNIQUE¿¿ MEANING THE DEVICE IS NOT INTENDED FOR HIGH LOAD APPLICATION. FURTHER, THE OP-TECH REQUIRES OBSERVATION BY IMAGING DURING COMPRESSING THE BONE FRAGMENTS. BY DOING THIS IT CAN BE OBSERVED WHEN THE LOCKING SCREWS DEFORMS ¿ INDICATING COMPRESSION IS AT THE MAXIMUM AND REQUIRES NO MORE LOAD APPLICATION. REFERRING TO THE PERIOD SINCE DISTRIBUTION, ROUGHLY 15 YEARS AGO, IT WAS CONCLUDED THAT THE COMPRESSION SCREWDRIVER HAD FULFILLED ITS TASKS AS INTENDED. AS INSPECTION OF THE RETURNED PRODUCT REVEALED NO DEFICIENCY THE REPORTED EVENT HAS TO BE CLASSIFIED AS NOT DEVICE RELATED. THE EVENT WAS CAUSED BY APPLIED OVERLOAD DURING THE COMPRESSION PROCEDURE WHICH WAS REGARDED AS A USER RELATED. THE EVENT WAS NOT CAUSED BY DEFICIENCY OF THE DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE SCREWDRIVER BROKEE OFF AT COUPLING PIECE DURING OPERATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREWDRIVER BROKE OFF AT COUPLING PIECE DURING OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65825 SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K0AB609 04546540196330

    Patients

    Seq Age Sex Outcome Treatment
    1 Other