BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 4623904 · Received March 23, 2015

    Report

    Report Number
    1719045-2015-10181
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND 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.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE COMPLAINT CONDITION FOR THE 456.315 LOT NUMBER 7931348 170MM TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL WAS LIKELY CAUSED BY THE ACCIDENTAL ACTIVATION OF THE LOCKING MECHANISM OF THE NAIL PRIOR TO INSERTING THE HELICAL BLADE; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO PRODUCT ISSUE WAS NOTED UPON EXAMINATION OF THE RETURNED 456.303 LOT NUMBER 7847995 HELICAL BLADE, 357.366 LOT NUMBER 3773903 AIMING ARM, 357.411 LOT NUMBER 5685473 INSERTION HANDLE, 357.369 LOT NUMBER 6624486 BLADE GUIDE SLEEVE, 357.371 LOT NUMBER 6599561 BUTTRESS/COMPRESSION NUT, 357.377 LOT NUMBER 7033371 COUPLING SCREW, AND 357.372 LOT NUMBER 6538658 HELICAL BLADE INSERTER. 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

    PATIENT ID: (B)(6). ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF DEPUY SYNTHES (B)(4) DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. 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

    IT WAS REPORTED WHILE DOING A TROCHANTERIC FIXATION NAIL (TFN) SURGERY, THE HELICAL BLADE WAS NOT ABLE TO PASS THROUGH THE NAIL; IT WAS GETTING CAUGHT ON THE NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A NEW HELICAL BLADE, NAIL AND NEW SET OF INSTRUMENTS. THERE WAS SURGICAL DELAY OF MORE THAN ONE HOUR REPORTED. THIS IS REPORT 2 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192756 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7931348

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention