BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 100MM STERILE

    MDR report key: 6090636 · Received November 9, 2016

    Report

    Report Number
    3003506883-2016-10181
    Event Type
    Injury
    Date Received
    November 9, 2016
    Report Date
    October 19, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. PATIENT DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART#04.038.300S, LOT#7954175. PART MFG DATE: 30 MARCH 2015, PART EXP. DATE: 28 FEBRUARY 2025. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 100MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. 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. INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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, THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE DUE TO TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE 100MM BACKING OUT. THE PATIENT HAD NOTED THAT SHE WAS "FEELING IT ON THE SIDE OF HER LEG". AN X-RAY ON AN UNKNOWN DATE HAD ALSO REVEALED THE BACKING OUT OF THE BLADE. THE DATE OF ORIGINAL IMPLANTATION WAS UNKNOWN. THE BROKEN TFNA HELICAL BLADE WAS REMOVED DURING THE REVISION PROCEDURE. THE NAIL AND LOCKING SCREW WERE NOT REMOVED. A SHORTER BLADE WAS THEN IMPLANTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT OUTCOME WAS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT#-UNKNOWN, QUANTITY# UNKNOWN) CONCOMITANT DEVICE REPORTED: NAIL (PART# UNKNOWN, LOT#-UNKNOWN, QUANTITY #UNKNOWN) CONCOMITANT DEVICE REPORTED: END CAPS (PART# UNKNOWN, LOT#-UNKNOWN, QUANTITY #UNKNOWN) THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 100MM. THIS IS REPORT 1 OF 1 FOR COM-(B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739816 TFNA HELICAL BLADE 100MM STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 7954175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN QUANTITY OF UNKNOWN END CAPS| UNKNOWN QUANTITY OF UNKNOWN NAIL| UNKNOWN QUANTITY OF UNKNOWN SCREWS