BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 6976367 · Received October 25, 2017

    Report

    Report Number
    3003875359-2017-10534
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 6, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MAX
    UDI-DI
    10705034727790
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE REPORT INDICATES THAT THE: FOLLOWING DEVICE WAS RETURNED FOR CQ INVESTIGATION; RATCHET PALM GRIP HANDLE 6MM QC P/N 03.632.098, LOT# 6760898 T-PAL APPLICATOR INNER SHAFT P/N 03.812.003, LOT L390623. THE RETURNED INNER SHAFT WAS RETURNED WITH ONE OF THE TWO DISTAL FORKS IN A BROKEN AND MISSING CONDITION. THE OTHER FORK IS BENT. THE SHAFT HAS SOME SCRATCH MARKS AROUND THE MIDDLE PORTION WHICH WERE PROBABLY CREATED BY THE USER DURING AN ATTEMPT TO SEPARATE THE IT FROM THE SPACER IMPLANT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BEHIND THE SURGEON HAVING DIFFICULTY REMOVING THE TPAL SPACER APPLICATOR INNER SHAFT FROM THE IMPLANT HOWEVER, THE FAILURE IS TYPICALLY ASSOCIATED WITH EXCESSIVE TORSIONAL LOADING AS A RESULT OF IMPROPER SURGICAL TECHNIQUE. THE EXCESSIVE FORCE APPLIED BY THE USER (AS DESCRIBED IN THE COMPLAINT DESCRIPTION) CAUSED THE INNER SHAFT TIP TO BEND AND BREAK. HENCE, THE COMPLAINT CONDITION IS CONFIRMED. THE COMPLAINT WAS UNABLE TO BE REPLICATED DUE TO VISIBLE POST-MANUFACTURING DAMAGE. A VISUAL INSPECTION, FUNCTIONAL TEST (AS APPLICABLE), DRAWING REVIEW AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. DURING THE DRAWING REVIEW NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO MANUFACTURING OR DESIGN RELATED ISSUE WAS IDENTIFIED DURING DHR REVIEW. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES WITH THE MATERIAL AND DURING THE MANUFACTURING OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH 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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER L286749. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 19.APR.2017. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT 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 A PATIENT UNDERWENT A T9-PELVIS FUSION AND A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L2-L3 USING THE SYNTHES MATRIX AND TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR TPAL CAGE SYSTEMS ON (B)(6) 2017. DURING THE PROCEDURE, WHILE THE SURGEON WAS TAPPING THE SCREWS, THE SURGEON HAD DIFFICULTY ALTERNATING THE RATCHET PALM GRIP HANDLE WITH 6MM QUICK COUPLING FROM FORWARD TO REVERSE, INDICATING THAT THE FUNCTION WAS VERY "STICKY". LATER, AFTER THE SURGEON HAD SUCCESSFULLY IMPLANTED THE 13MM PEEK 10X28MM TPAL CAGE, THE SURGEON HAD DIFFICULTY REMOVING THE TPAL SPACER APPLICATOR INNER SHAFT FROM THE IMPLANT. AFTER VIGOROUSLY MOVING THE APPLICATOR INNER SHAFT BACK AND FORTH, ONE OF THE STYLETS OF THE INNER SHAFT BROKE OF AND REMAINED STUCK INSIDE OF THE PATIENT. UTILIZING A KOCHER'S FORCEPS, THE SURGEON REMOVED THE FRAGMENT AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WAS A DELAY OF APPROXIMATELY ONE MINUTE WITHOUT ANY PATIENT HARM REPORTED. CONCOMITANT DEVICES REPORTED: TPAL CAGE (PART #: 08.812.012, LOT #: UNKNOWN, QTY. 1), MATRIX SCREWS (PART #: 04.639.XXX, LOT #: UNKNOWN, QTY. 20). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756743 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES HAGENDORF 03.812.003 L286749 10705034727790

    Patients

    Seq Age Sex Outcome Treatment
    1