BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE

    MDR report key: 7010738 · Received November 8, 2017

    Report

    Report Number
    1719045-2017-11161
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 15, 2017
    Report Date
    October 15, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT NOT PROVIDED FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES REPORTED: TFNA SCREW 115 MM - STERILE, PART #-04.038.115S, LOT #-7992346, QUANTITY (1). TFNA HELICAL BLADE 115 MM. STERILE, PART #-04.038.315S, QUANTITY (1). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24-JUN-2016, EXPIRATION DATE: 31-MAY-2026. PART #: 04.037.158S, LOT#: H414393 (STERILE) - 11 MM/130 DEG TI CANN TFNA 380 MM/RIGHT- STERILE. QTY. 5. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL NS063045 REV: K AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION NS067861 REV: B MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED AND IT MEET SPECIFICATION: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT ¿ L415705, 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ H316267, 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ H407579, (B)(4). 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. (B)(4)(ETHICON (ABQ)), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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 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 DURING AN INITIAL RIGHT FEMUR SURGERY ON (B)(6) 2017, THE SET SCREW INTERLOCKING MECHANISM INSIDE THE NAIL WAS DISCOVERED TO BE ALREADY ADVANCED. THIS INHIBITED THE ABILITY OF THE SURGEON TO IMPLANT THE HELICAL BLADE THROUGH THE NAIL. THE HELICAL BLADE WAS NOT GOING THROUGH THE NAIL. THE SURGEON THEN REMOVED THE HELICAL BLADE AND USED A LAG SCREW FROM ANOTHER SET IN PLACE OF THE HELICAL BLADE. THE SURGEON HAD A SIMILAR EXPERIENCE WITH THE LOCKING MECHANISM OF THE NAIL WHILE TRYING TO IMPLANT THE LAG SCREW. THE SURGEON THEN LOOSENED THE LOCKING MECHANISM OF THE NAIL AND THE LAG SCREW WAS ABLE TO ADVANCE INTO THE BONE WITHOUT ANY FURTHER INCIDENT. THIS CAUSED A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE HELICAL BLADE WAS DISPOSED OF AT THE HOSPITAL. THE LAG SCREW AND THE NAIL REMAIN INSIDE THE PATIENT. THERE WAS NO FRAGMENTATION OR ANY BROKEN PIECES TO THE DEVICES. NONE OF THE DEVICES WILL BE RETURNING TO SYNTHES. THIS COMPLAINT HAS 1 DEVICE. CONCOMITANT DEVICES REPORTED: TFNA SCREW 115 MM - STERILE, PART #-04.038.115S, LOT #-7992346, QUANTITY (1). TFNA HELICAL BLADE 115 MM. STERILE, PART #-04.038.315S, QUANTITY (1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788725 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H414393

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR