BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 5426889 · Received February 10, 2016

    Report

    Report Number
    1719045-2016-10125
    Event Type
    Injury
    Date Received
    February 10, 2016
    Report Date
    January 13, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ORIGINAL IMPLANT PROCEDURE TOOK PLACE ON AN UNKNOWN DATE IN (B)(6) 2015. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JULY 13, 2015 - EXPIRATION DATE: JUNE 30, 2025. 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. THE STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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. 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

    A PRODUCT EVALUATION & INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: PD SUMMARY FOR PIA¿S 002892 AND 002893: AS RECEIVED CONDITION: NAIL: DESCRIPTION GIVEN WILL BE AS VIEWING THE NAIL FROM THE LATERAL SIDE LOOKING AT LATERAL RELIEF. MEDIAL SIDE OF NAIL ON THE SURFACE BETWEEN THE OBLIQUE HOLE AND THE PROXIMAL END OF THE NAIL EXHIBITS SCORE MARKS AND SCUFF MARKS. THE LEFT SIDE OF THE OBLIQUE HOLE SHOWS EVIDENCE THAT A DEVICE SCRAPED THE SURFACE IN A RADIAL FASHION. THERE IS ALSO A LONGITUDINAL SCRATCH IN THE SAME AREA. THE RIGHT SIDE OF THE OBLIQUE HOLE EXHIBITS DEEP RADIAL SCORE MARKS AS IF MADE BY A SCREW TAP. THE LOCKING MECHANISM EXHIBITS MINOR DEBRIS AND THE BOTTOM WAVE OF THE WAVE SPRING HAS DROPPED INTO THE CREVICE OF THE TOP OF THE LOCK PRONG. BLADE: THERE ARE DARK COLORED SCUFF MARKS ON INFERIOR AND SUPERIOR SURFACE INDICATING THAT THE BLADE HAD AT SOME POINT TIME COLLAPSED FULLY AND WAS STOPPED BY THE LOCK PRONG ASSEMBLY. THE BLADE ALSO EXHIBITS RUB MARKS 15MM AND 34MM FROM THE LATERAL END ON THE SUPERIOR SURFACE INDICATING THAT THERE MAY HAVE BEEN CONTACT WITH THE SERRATIONS OF THE LOCK PRONG AND THE ANODIZE HAS BEEN WORN AWAY EXPOSING THE BASE METAL. THE EXTERNAL EDGES OF THE HELICAL FLUTES EXHIBIT ABRASIONS EXPOSING BASE METAL LOCKING SCREW (Ø5.0MM X 38MM): EXHIBITS NORMAL WEAR WITH NO ISSUES. ALL DEVICES APPEAR TO BE IN WORKING ORDER. SINCE NO X-RAY IMAGES WERE PROVIDED AND THERE IS NO DETAILED INFORMATION PROVIDED, IT IS VERY DIFFICULT TO PROPERLY INVESTIGATE THIS COMPLAINT, THEREFORE, SELECTED ¿NOT APPLICABLE¿ FOR ¿DOES THE CONDITION AGREE WITH THE COMPLAINT DESCRIPTION?¿ BECAUSE THE COMPLAINT DOES NOT DESCRIBE THE CONDITION OF WHAT WAS FOUND WHEN REVIEWING THE FEATURES OF THE DEVICE. PER THE LITERATURE THIS INCIDENT IS VERY RARE AND CAN NOT BE PREDICTED BASED ON IMMEDIATE POST-OP RADIOGRAPHS. FOLLOW-UP X-RAYS ARE NORMALLY REVIEWED AND IF THERE IS AN ONSET OF MIGRATION ACTION SHOULD BE TAKEN TO CORRECT THE SITUATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL (TFN) EXPLANT PROCEDURE, WITH REVISION TO A TOTAL HIP ARTHROPLASTY, WAS PERFORMED ON (B)(6) 2016. THE PROCEDURE WAS SCHEDULED FOLLOWING THE DISCOVERY OF HELICAL BLADE MIGRATION AND A COLLAPSED FEMORAL HEAD. THE PATIENT AND PROCEDURAL OUTCOMES ARE UNKNOWN, BUT THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84530 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9848739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention