BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 5695330 · Received June 2, 2016

    Report

    Report Number
    3003875359-2016-10331
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Report Date
    May 17, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MAX
    PMA / PMN Number
    PK151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE RETURNED INSTRUMENTS WERE EXAMINED AND THE COMPLAINT CONDITIONS WERE ABLE TO BE CONFIRMED IN EACH INSTANCE. THE THREADED TIP OF ONE HOLDING SLEEVE (PART 03.632.123 / LOT 7888311) WAS FOUND TO BE CRACKED AND PEELING, BUT IT WAS INTACT. THE THREADED TIP FOR THE OTHER HOLDING SLEEVE (PART 03.632.123 / LOT 9802886) WAS FOUND TO BE BROKEN WITH A SEGMENT OF THE DISTAL-MOST THREAD MISSING (APPROXIMATELY 0.6MM X 5.5MM X 2MM). FINALLY, THE PROXIMAL COUPLING HEAD OF THE T-PAL SPACER APPLICATOR (PART 03.812.003 / LOT 9652895) WAS BROKEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS WITH NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES IDENTIFIED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE RETURNED INNER SHAFT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE PROXIMAL COUPLING HEAD WAS FOUND TO BE BROKEN OFF AND NOT RETURNED. THE DISTAL PRONGS WERE FOUND TO BE INTACT WITHOUT SIGNS OF DEFORMATION; THE REMAINDER OF THE DEVICE WAS FOUND TO BE INTACT WITH MINIMAL WITNESS MARKS CONSISTENT WITH WEAR AND TEAR. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): INNER SHAFT. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. ENDURANCE TESTING (INSERTION AND REMOVAL) WAS COMPLETED WITH NO FUNCTIONAL FAILURES OBSERVED 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. THE RECEIVED FAILURE MODE IS CONSISTENT WITH IMPACTION WHILE THE HANDLE SECURITY RING IS PRESSED FORWARD; THIS WOULD CONCENTRATE IMPACTION FORCES ON THE PROXIMAL COUPLING BALL TIP. HOWEVER, NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE ITEM 03.812.003- LOT # 9652895, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24.NOV.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. 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

    CLARIFICATION: IT WAS ORIGINALLY REPORTED THAT THREE (3) INSTRUMENTS WERE FOUND TO BE DAMAGED DURING AN INSPECTION OF FIELD EQUIPMENT. TWO (2) HOLDING SLEEVES WERE SAID TO BE WORN OUT AT THE THREADED DISTAL TIPS, WHILE THE BALL END TIP OF A TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER APPLICATOR HAD BROKEN OFF. NO REPORTED PATIENT OR SURGICAL INVOLVEMENT WITH THESE EVENTS. UPDATE: UPON INVESTIGATION OF THE RETURNED DEVICES, WHICH WAS COMPLETED ON JUNE 3, 2016, IT WAS DETERMINED THAT ONE OF THE HOLDING SLEEVES HAD ACTUALLY BROKEN/FRAGMENTED AS WELL. THE DEVICE HAS BEEN RE-ASSESSED FOR REPORTABILITY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON MAY 17, 2016 WHILE THE SALES CONSULTANT (SC) WAS REVIEWING HIS FIELD EQUIPMENT, HE NOTED THE FOLLOWING THREE INSTRUMENTS WERE BROKEN: TWO (2) HOLDING SLEEVES REPORTED WITH THREADED DISTAL TIPS AS WORN OUT. ALSO, ONE (1) T-PAL SPACER APPLICATOR REPORTED THAT THE BALL END TIP IS BROKEN OFF AT THE PROXIMAL END. SALES CONSULTANT HAS NO MORE INFORMATION TO PROVIDE TO THIS EVENT. THIS REPORT IS FOR 1 DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350023 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES HAGENDORF 9652895

    Patients

    Seq Age Sex Outcome Treatment
    1