BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFNA HELICAL BLADE 105MM- STERILE

    MDR report key: 5946920 · Received September 13, 2016

    Report

    Report Number
    3003506883-2016-10156
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 21, 2016
    Report Date
    August 21, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ONE TFNA HELICAL BLADE 105MM STERILE PART # 04.038.305S, LOT # H07333, MAY 19, 2016 WAS RETURNED TO MANUFACTURER. UPON INSPECTION THERE IS NO EVIDENCE THAT THIS IMPLANT CONTRIBUTED TO THE COMPLAINT CONDITION AS THE ISSUES FOR THE BLADE JAMMING WAS CAUSED BY THE LOCKING MECHANISM BEING ENGAGED PRIOR TO INSERTION THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. 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

    ADDITIONAL NARRATIVE: (B)(4). DEVICE MALFUNCTION WAS NOTED DURING THE IMPLANT PROCEDURE. DEVICE WAS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW: MANUFACTURE DATE: 19-MAY-2016. EXPIRATION DATE: 30-APR-2026. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 105MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. HOWEVER BEFORE STERILIZATION, THE WORK ORDER WAS SPLIT TO INCLUDE A THERMAL RINSE PROCESS. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT WAS SPLIT FROM THE ORIGINAL LOT H073333 TO LOT H102253 PRIOR TO OP 120 GENERATE LABEL. THEREFORE THE ORIGINAL LOT H073333 WAS ALREADY LASER MARKED ON THESE PARTS. AFTER THE LOT WAS SPLIT DUE TO ADDITIONAL CLEANING STEPS PRIOR TO STERILIZATION, THE LOT NUMBER CHANGED TO H102253 WHICH WAS PRINTED ON THE LABEL AT OP (B)(4) GENERATE LABEL. THIS RESULTS IN THE LOT NUMBERS ON THE LASER MARKED PARTS NOT BEING THE SAME AS THE LOT NUMBER ON THE PACKAGING LABELS. LOT INTEGRITY AND TRACEABILITY IS MAINTAINED. THIS DOES NOT CONTRIBUTE TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT SURGERY ON A LEFT HIP FRACTURE. DURING THE SURGERY, IT WAS NOTED THAT THERE WAS A MALFUNCTION WITH THE IMPLANT. IT WAS BELIEVED THAT THE LOCKING MECHANISM IN THE TFN-ADVANCED SHORT NAIL WAS ALREADY DOWN AND RECEIVED IN THAT CONDITION FOLLOWING SHIPMENT; THIS WAS NOT NOTED PRIOR TO ATTEMPTED IMPLANTATION. WHEN THE HELICAL BLADE WAS INSERTED, IT GOT JAMMED IN THE NAIL. BOTH THE BLADE AND NAIL WERE REMOVED AND OTHER PARTS WERE IMPLANTED. THERE WAS A 20-MINUTE DELAY IN SURGERY WITH NO REPORTED PATIENT HARM. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 105MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599694 TFNA HELICAL BLADE 105MM- STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA H073333

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR