BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 5658161 · Received May 16, 2016

    Report

    Report Number
    3003875359-2016-10305
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PK151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. 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. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (T-PAL SPACER APPLICATOR KNOB, PART NUMBER 03.812.004, LOT NUMBER 9811196). THE SUBJECT DEVICE WAS RETURNED WITH ASSOCIATED T-PAL APPLICATOR HANDLE. THE RETURNED INSTRUMENTS WERE EXAMINED AND THE HANDLE/KNOB CONSTRUCT WAS UNABLE TO BE ASSEMBLED AS THE KNOB WAS UNABLE TO FULLY THREAD ONTO THE HANDLE. WEAR IS VISIBLE ON BOTH THREADED SURFACES WHICH WOULD INHIBIT DEVICE ASSEMBLY. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH ROUGH HANDLING/CROSS THREADING. CROSS THREADING IS POSSIBLE AS THE KNOB IS ATTACHED TO THE HANDLE WITH REVERSE THREADS. ALTHOUGH THE KNOB HAS CLEAR LABELING INDICATING WHICH DIRECTION IT MUST BE TURNED FOR ASSEMBLY, CONFUSION IS POSSIBLE AS IT MAY BE COUNTERINTUITIVE TO THOSE UNFAMILIAR WITH THE SYSTEM. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. CONCOMITANT MEDICAL PRODUCTS: PART 03.812.001, T-PAL SPACER APPLICATOR HANDLE WAS DETERMINED TO BE REPORTABLE AND WAS REPORTED IN A SEPARATE REPORT. 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 PREPARATION FOR A TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER PROCEDURE AT L5-S1, AFTER LOADING THE 9MM - 10MM X 28MM IMPLANT ONTO THE T-PAL APPLICATOR, THE IMPLANT WOULD NOT RELEASE FROM THE T-PAL APPLICATOR. IT IS REPORTED THE APPLICATOR KNOB WOULD NOT TURN, THUS PREVENTING THE IMPLANT FROM RELEASING FROM THE APPLICATOR INNER SHAFT. IT IS FURTHER REPORTED PATIENT WAS IN THE ROOM AND UNDER ANESTHESIA, BUT DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. ANOTHER APPLICATOR AND IMPLANT WERE READILY AVAILABLE AND WERE USED TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311978 T-PAL SPACER APPLICATOR KNOB INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR LXH SYNTHES HAGENDORF 9811196

    Patients

    Seq Age Sex Outcome Treatment
    1