BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    MDR report key: 6659178 · Received June 21, 2017

    Report

    Report Number
    9612488-2017-10276
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 25, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT AGE, DOB & WEIGHT NOT PROVIDED FOR REPORTING. (B)(4). ADDITIONAL CLASSIFICATION CODE: HRS. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT MEDICAL PRODUCT THERAPY DATE IS UNKNOWN. (B)(6). ADDITIONAL 510K: K102694. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE RECEIVED DEVICE WAS BROKEN BETWEEN SCREW HEAD AND THREADED SHAFT. THE BROKEN SHAFT WAS NOT RETURNED. BECAUSE OF THE DAMAGE AND WITHOUT BROKEN PARTS THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY. THE MANUFACTURING REVIEW COULD NOT BE PERFORMED AS RELEVANT LOT NUMBERS ARE NOT KNOWN AT THIS TIME. DUE TO LIMITED INFORMATION AVAILABLE IN THE COMPLAINT DESCRIPTION, IT CANNOT BE CONFIRMED HOW THIS HAPPENED. POSSIBLE CAUSE OF THE BREAKAGE COULD BE THE MECHANICAL OVERLOAD SITUATION DURING USE. 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

    PATIENT GENDER CORRECTION FROM MALE TO FEMALE. 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

    THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. CORRECTED DATA: THERAPY DATE OF CONCOMITANT DEVICE. 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 SURGERY TWO LOCKING SCREWS BROKE AT THE HEAD WHEN USING THE TORQUE LIMITER. THE SURGERY WAS NOT PROLONGED. PATIENT OUTCOME IS GOOD. THERE WAS NO HARM TO THE PATIENT. THE SURGEON OPTED FOR A LARGER PLATE IN THIS CASE AND HAD ALREADY BLOCKED SOME SCREWS THAT WOULD HAVE BEEN ENOUGH, CHOOSING NOT TO REMOVE THE BODY FROM THE SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT REPORTED PART: 1X TORQUE LIMITER, 0.8 NM (PART 511.776 LOT UNKNOWN) THIS REPORT IS 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438879 2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM SCREW, FIXATION, BONE HWC SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1