BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 5483724 · Received March 7, 2016

    Report

    Report Number
    2520274-2016-11505
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 13, 2016
    Report Date
    February 13, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PK151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE RETURNED T-PAL SPACER APPLICATOR INNER SHAFTS (03.812.003) ((B)(4)) AND T-PAL SPACER APPLICATOR KNOBS (03.812.004) ((B)(4)) ARE UTILIZED IN THE T-PAL (TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR) SYSTEM ((B)(4)). THIS INVESTIGATION ADDRESSES PARTS FROM TWO BROKEN INNER SHAFT COUPLING HEAD COMPLAINTS ((B)(4)), BECAUSE THE SC COULD NOT PROVIDE THE LOT NUMBERS FOR THESE DEVICES, IT CANNOT BE DETERMINED WHICH PART/LOT NUMBER COMBINATIONS GOES WITH WHICH COMPLAINT. THE COMPLAINT CONDITIONS STATED THAT IT WAS UNCLEAR WHEN THE COUPLING HEADS BROKE BECAUSE IN BOTH CASES THE DEVICE FUNCTIONED AS EXPECTED. DURABILITY OF INNER SHAFTS WAS VALIDATED BY ENDURANCE TESTING (INSERTION AND REMOVAL), WHICH WAS COMPLETED WITH NO FUNCTIONAL FAILURES AFTER 100 SIMULATED APPLICATION CYCLES. DYNAMIC IMPACT LOADING WAS BENCHMARKED FROM CADAVER TESTING WHERE LOADING DURING INSERTION WAS MEASURED AT APPROXIMATELY 10KN IN A NORMAL CASE (APPROPRIATE IMPLANT/TRIAL SIZE SELECTED). THE COMPLAINT CONDITIONS ARE CONSISTENT WITH IMPACTION PRIOR TO THE APPLICATOR KNOB BEING TURNED UNTIL IT STOPS AT THE SECURITY RING, WHICH CAN CONCENTRATE IMPACTION FORCES ON THE PROXIMAL COUPLING BALL TIP, MAKING IT VULNERABLE TO BREAKAGE. ALTHOUGH IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION, BASED ON THE AVAILABLE INFORMATION AND THE GUIDANCE PROVIDED IN THE T-PAL TECHNIQUE GUIDE, IT IS MOST LIKELY DUE TO USE OF IMPROPER TECHNIQUE. THE RETURNED DEVICES AND ADDRESSES THE HAZARD OF BREAKAGE OF THE PROXIMAL PIN OF THE INNER SHAFT DUE TO EXCESSIVE HAMMERING IN LINE. THIS INVESTIGATION SUMMARY IS APPROVED 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    ADDITIONAL NARRATIVE: LOT: TWO (2) 03.812.003 WERE RECEIVED FOR (B)(4). IT WAS NOT ABLE TO BE DISTINGUISHED WHICH PART / LOT NUMBER COMBINATION MATCHED ITS RESPECTIVE COMPLAINT. THE LOT NUMBER FOR THIS DEVICE IS EITHER 9248230 OR 8662483. THE DHR, AND POSSIBLE UDI / MANUFACTURING DATE FOR BOTH LOT NUMBERS ARE PROVIDED BELOW. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. LOT 9248230: MANUFACTURING DATE: 13.FEB.2015. LOT 8662483 - MANUFACTURING DATE: 30.JAN.2014. DHR REVIEW - DHR REVIEW FOR LOT 9248230 - MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 13.FEB.2015. 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. DHR REVIEW - LOT 8662483 - MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 30.JAN.2014. 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 IS REPORTED THAT AFTER AN OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT LEVELS L4 TO L5, IT WAS NOTICED THAT THE PROXIMAL END OF THE T-PAL SPACER APPLICATOR INNER SHAFT BROKE OFF AND IS LODGED IN THE T-PAL SPACER APPLICATOR KNOB. IT CANNOT BE VERIFIED THAT THIS OCCURRED DURING THE PROCEDURE, AS THE DEVICE FUNCTIONED AS EXPECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140683 T-PAL SPACER APPLICATOR INNER SHAFT MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR