BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9MM/125 DEG TI CANN TFNA 235MM/RIGHT-STERILE

    MDR report key: 7104335 · Received December 11, 2017

    Report

    Report Number
    8030965-2017-50488
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 13, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819651722
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.037.914S, LOT# H251098. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: DEC 14, 2016, EXPIRY DATE: DEC 31, 2026. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.914.2 - LOCK PRONG 125 DEGREE, TFNA BP-55 LOT - L106372; 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 9937547 ; 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H197786(4), H197470(2); 21127 - RAW MATERIAL LOT BP-80 LOT - H123944. RAW MATERIAL WAS RECEIVED FROM (B)(4), CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS FOR TITANIUM MEET SPECIFICATION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE EXTERNAL CONDITION OF THE NAIL UPON RECEIPT WAS IN GOOD CONDITION. THE CONDITION OF THE HELICAL BLADE WAS ALSO GOOD. THE HELICAL BLADE WAS PLACED INSIDE OF THE OBLIQUE HOLE OF THE NAIL AND IT FIT EASILY. A 5MM HEX WRENCH WAS PLACED INTO THE LOCK DRIVE AND THE WRENCH WAS TURNED TO TIGHTEN THE LOCKING MECHANISM. IT TIGHTENED FINE, WITH THE LOCK PRONG SUCCESSFULLY HOLDING THE HELICAL BLADE PLACE. THE LOCKING MECHANISM WAS REMOVED AND APPEARED FAIRLY COVERED WITH HUMAN TISSUE. THERE WERE ALSO SCRATCHES ON THE TOP OF THE LOCK DRIVE. THE AVAILABLE DATA DOES NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION OF "MALFUNCTION" OR ¿FROZEN¿; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. AS DESCRIBED EARLIER, THE LOCKING MECHANISM WORKED CORRECTLY AND SUCCESSFULLY LOCKED THE HELICAL BLADE IN PLACE. AS SUCH, THE CAUSE OF THE INABILITY OF THE PHYSICIAN TO TIGHTEN THE LOCKING MECHANISM COULD NOT BE DETERMINED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    Additional Manufacturer Narrative · 1

    DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN FEMUR TROCHANTERIC FRACTURE ON (B)(6) 2017. AFTER THE HELICAL BLADE WAS INSERTED, THE SURGEON TRIED TO FIX A SETSCREW WHICH ORIGINALLY CAME WITH TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL IN QUESTION. BUT THE SETSCREW WAS NOT ABLE TO BE LOCKED AT ALL. ALTHOUGH THE SURGEON TRIED TIGHTENING WITH A FLEXIBLE DRIVER AND A TORQUE DRIVER, IT DID NOT WORK. THUS, BOTH THE NAIL AND THE BLADE WERE REPLACED WITH NEW ONES, AND THE SETSCREW WAS FIXED IN PLACE. THE SURGERY WAS COMPLETED WITH A SIXTY (60) MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. SURGEON COMMENTED THAT HE PERFORMED THE SURGERY AS PER IFU. CONCOMITANT DEVICES REPORTED: FLEXIBLE DRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), TORQUE DRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), TFNA HELICAL BLADE, L 90MM (PART # 04.038.290S, LOT # H322426, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9MM/125 DEG TI CANN TFNA 235MM/RIGHT-STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884184 9MM/125 DEG TI CANN TFNA 235MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H251098 07611819651722

    Patients

    Seq Age Sex Outcome Treatment
    1