BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE 2.4MM

    MDR report key: 4772152 · Received May 14, 2015

    Report

    Report Number
    3003875359-2015-10211
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 24, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION EVALUATION WAS PERFORMED ¿ TWO PEDICLE PROBES (03.614.012 LOTS 3092454 AND 8473256) WERE RETURNED. THE RETURNED INSTRUMENTS WERE EXAMINED AND IN BOTH CASES THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THEY WERE RETURNED WITH TWISTED TIPS. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED, HOWEVER BASED ON THE COMPLAINT DESCRIPTION; THE SURGEON USED THE PROBES AS IF THEY WERE AWLS, APPLYING FORCES WHICH THE INSTRUMENTS WERE NOT INTENDED TO WITHSTAND. THE COMPLAINT IS CONFIRMED. THE RETURNED INSTRUMENTS WERE EVALUATED AND THE COMPLAINT CONDITION OF TWISTED WAS ABLE TO BE CONFIRMED IN EACH INSTANCE AS THE DISTAL 10MM WERE TWISTED. WHEN PREPARING A PEDICLE PRIOR TO SCREW INSERTION FOR THE SYNAPSE SYSTEM A PILOT HOLE IS CREATED USING AN AWL AFTER WHICH THE HOLE CARE BE DRILLED TO THE PROPER DEPTH USING THE APPROPRIATE DRILL BIT. WITH THE HOLE DRILLED ONE OF THE SYSTEM PROBES IS UTILIZED TO CONFIRM PROPER PLACEMENT OF THE HOLE THROUGH PALPATION. IF THE COMPLAINT DESCRIPTION IS ACCURATE AND THE PEDICLE PROBE WAS UTILIZED AS AN AWL, THEN THE COMPLAINT CONDITION OF A TWISTED TIP WOULD BE THE LIKELY OUTCOME AS THE PROBE IS NOT INTENDED TO BREAK THROUGH CORTICAL BONE AND WILL DEFORM UNDER THE NECESSARY FORCES. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. 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

    ADDITIONAL NARRATIVE: 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURING REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: APRIL 23, 2009. NO NON-CONFORMANCE REPORTS 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 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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT TWO (2) AWL DEVICES BECAME TWISTED DURING A POSTERIOR LUMBAR DECOMPRESSION FUSION PROCEDURE ON (B)(6) 2015. THE SURGEON WAS USING THE AWL ON A SMALL PEDICLE WITH HARD BONE WHEN IT BECAME TWISTED. THE SAME RESULT OCCURRED WITH THE ATTEMPT USING A SECOND AWL. AN ALTERNATE AWL DEVICE WAS AVAILABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS REPORTED AS BEING STABLE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315834 PEDICLE PROBE 2.4MM PROBE HXB SYNTHES HAGENDORF 3092454

    Patients

    Seq Age Sex Outcome Treatment
    1