BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4649462 · Received April 1, 2015

    Report

    Report Number
    1719045-2015-10207
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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. PATIENT INFORMATION NOT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. AEROMED, INC. MANUFACTURED THE INSERTION HANDLE, P/N 357.411 ON LOT #6702030. THE PRODUCT WAS RELEASED TO THE WAREHOUSE ON SEPTEMBER 21, 2011. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 INVESTIGATION WAS COMPLETED: FIVE INSTRUMENTS BELONGING TO THE TROCHANTERIC FIXATION NAIL SYSTEM, ONE 130° AIMING ARM (PART 357.366, LOT 5672730, MANUFACTURED DECEMBER 17, 2007), ONE INSERTION HANDLE(PART 357.411, LOT 6702030, MANUFACTURED SEPTEMBER 21, 2011), 11.0MM/8.0MM PROTECTION SLEEVE(PART 357.386, LOT 5591148, MANUFACTURED NOVEMBER 27, 2007), 8.0MM/4.0MM DRILL SLEEVE (PART 357.389, LOT 5565986, MANUFACTURED AUGUST 28, 2007), AND ONE CANNULATED CONNECTING SCREW(PART 357.397, LOT 5217617, MANUFACTURED JUNE 22, 2006) WERE RETURNED. UPON RECEIPT OF THESE DEVICES IT WAS SEEN THAT THE INSTRUMENTATION CAN BE ASSEMBLED TOGETHER AS DESIGNED, AND ALL RETURNED PARTS SHOW MINIMAL SIGNS OF USE AND WEAR AND ARE IN OVERALL GOOD CONDITION. THIS COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINED, OTHER VARIABLES, DEVICES AND DYNAMIC CONDITIONS DURING THE SURGERY MAY HAVE INHIBITED THIS SYSTEM FROM FUNCTIONING AS INTENDED AT THE TIME THAT THIS COMPLAINT OCCURRED. THE TECHNIQUE GUIDE WAS REVIEWED FOR PROPER ASSEMBLY OF THESE DEVICES AND PROPER TECHNIQUE FOR DISTAL LOCKING OF SHORT NAILS. THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINED, OTHER VARIABLES AND CONDITIONS DURING THE SURGERY MAY HAVE CONTRIBUTED TO THE MISALIGNMENT. IT IS UNKNOWN IF THE CANNULATED CONNECTING SCREW WAS FULLY TIGHTENED TO THE NAIL, IF THE INSERTION HANDLE WAS PROPERLY SEATED IN THE NAIL, AND IF THE SYSTEM WAS PROPERLY ASSEMBLED WHILE DISTAL LOCKING WAS OCCURRING. THE DESIGNS OF THESE DEVICES ARE ADEQUATE FOR THEIR INTENDED USES AND DID NOT CONTRIBUTE TO THIS 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    UPDATE: IT WAS REPORTED THAT THE SURGEON ATTEMPTED INTERVENTION TO REMOVE THE DISTAL LOCKING SCREW, BUT WOUND UP LEAVING IT INSIDE THE PATIENT. OUTCOME WAS REPORTED AS AERAGE AS THE PATIENT'S BONE IS NOT GOOD QUALITY. ALSO, A 30+ MINUTE DELAY WAS NOTED.THIS IS REPORT 1 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN INSERTION SURGERY ON (B)(6) 2015, THE DISTAL LOCKING SCREW WAS OFF TARGET. THE 12 MM SORT BLADE AND THE 11 MM HELICAL BLADE WERE SUCCESSFULLY INSERTED. THERE WAS PATIENT INVOLVEMENT. PATIENT STATUS, OUTCOME, SURGICAL TIME DELAY, AND ANY SURGICAL MEDICAL INTERVENTION ARE UNKNOWN AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214600 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES MONUMENT 6702030

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR