BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 320MM/RIGHT - STERILE

    MDR report key: 6260174 · Received January 18, 2017

    Report

    Report Number
    1719045-2017-10029
    Event Type
    Injury
    Date Received
    January 18, 2017
    Report Date
    December 1, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW REQUEST: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 21-JAN-2016, EXPIRATION DATE: 31-DEC-2025: PART #: 04.037.152S, LOT#: 9983624 (STERILE) - 11MM/130 DEG TI CANN TFNA 320MM/RIGHT - STERILE, RAW MATERIAL LOT NO: 7612626 WAS REVIEWED & HAVE NO ISSUE. QUANTITY 6. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A RIGHT TROCHANTERIC FIXATION NAIL ADVANCED REVISION PROCEDURE THAT WAS PERFORMED ON (B)(6) 2016 DUE TO A NONUNION AND NAIL BREAKAGE. THE NAIL BROKE AT THE POINT WHERE IT INTERSECTS WITH THE HELICAL BLADE. THE ORIGINAL PROCEDURE WAS FOR A PROXIMAL FEMORAL RIGHT FRACTURE ON AN UNKNOWN DATE. IT IS UNKNOWN HOW THE NAIL BREAKAGE AND NONUNION WERE DISCOVERED. DURING THE REVISION THE BROKEN NAIL AND ALL FRAGMENTS WERE REMOVED WITHOUT DIFFICULTY. IN ADDITION, AN INTACT HELICAL BLADE AND INTACT DISTAL LOCKING SCREW WERE REMOVED WITHOUT DIFFICULTY. THE PATIENT WAS REVISED TO A LATERAL ENTRY FEMORAL NAIL. DURING THE REVISION WHILE DRILLING THE GREATER TROCHANTER THE CANNULATED DRILL BIT BROKE AT THE INTERSECTION OF THE CHUCK AND DRILL BIT. THE POWER SOURCE WAS A STRYKER 7000 POWER DRILL. NO FRAGMENTS FELL INTO THE PATIENT AND ALL FRAGMENTS WERE REMOVED FROM THE SURGICAL FIELD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT READILY AVAILABLE SYNTHES DRILL BIT AND ROUTINE, PLANNED X-RAYS WERE TAKEN. THERE WAS NO SURGICAL DELAY, ADDITIONAL MEDICAL INTERVENTION OR UNANTICIPATED X-RAYS PERFORMED. THERE WAS NO PATIENT HARM REPORTED; IT WAS NOTED THE PATIENT IS HEALING AS EXPECTED. THIS REPORT IS TO CAPTURE THE REVISION PROCEDURE. THE INTRA-OPERATIVE DRILL BIT BREAKAGE IS BEING CAPTURED AND REPORTED ON LINKED COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: DISTAL LOCKING SCREW (QUANTITY 1); 8.5 MM HELICAL BLADE (QUANTITY 1); 15.0 MM CANNULATED DRILL BIT LARGE QC/280 MM (PART 03.010.028, LOT 072613, QUANTITY 1); STANDARD 3.2 STARTING PIN (PART 357.399, QUANTITY 1); AND STRYKER 7000 POWER DRILL (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44498 11MM/130 DEG TI CANN TFNA 320MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9983624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 PART 03.010.028, LOT 072613, CANNULATED DRILLBIT| ONE (1) PART 357.399, LOT UNKNOWN, STARTING PIN| ONE (1) UNKNOWN 8.5MM HELICAL BLADE| ONE (1) UNKNOWN DISTAL LOCKING SCREW| ONE (1) UNKNOWN STRYKER 7000 POWER DRILL