BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 4624035 · Received March 23, 2015

    Report

    Report Number
    1719045-2015-10183
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HST
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DATE SHOULD BE (B)(6) 2015. 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 WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR REVIEW 357.371 LOT 6599561 RELEASED 04/18/11 & 06/20/11. (B)(4) MANUFACTURED THE BUTTRESS COMPRESSION NUT, P/N 357.371 AND LOT NUMBER 6599561, FOR PO 1243711. FOR BOTH RECEIPTS OF THIS LOT, THE SUPPLIERS C OF C STATES THAT ALL MARTS WERE MANUFACTURED TO REVISION B AND MET THE REQUIRED SPECIFICATIONS. (B)(4) PIECES WERE RETURNED TO THE SUPPLIER AND THE NCR WAS CLOSED 04/18/11. THE REMAINING (B)(4) PIECES WERE RELEASED TO THE WAREHOUSE 04/18/11. 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

    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 456.303 LOT NUMBER 7847995 HELICAL BLADE 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. IT IS LIKELY THAT THE LOCKING MECHANISM WAS ACCIDENTALLY ACTIVATED PRIOR TO INSERTION LEADING TO THIS COMPLAINT CONDITION. THE RETURNED 456.303 HELICAL BLADE WAS RECEIVED IN POOR CONDITION CONSISTENT WITH ATTEMPTED INSERTION AND HEAVY MALLETING. THE DEVICE WAS MANUFACTURED IN 11/2014 AND IS LESS THAN A YEAR OLD, NO PRODUCT ISSUE WAS IDENTIFIED IN THE COMPLAINT DESCRIPTION OR NOTED UPON EXAMINATION. THEREFORE, A REVIEW OF THE ASSESSMENT IS NOT APPLICABLE FOR THIS DEVICE. 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 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194103 BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION,APPARATUS,NON-POWERED HST SYNTHES MONUMENT 6599561

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention