BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER

    MDR report key: 5258512 · Received December 1, 2015

    Report

    Report Number
    1719045-2015-10783
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PK000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE HEAD OF ONE (1) TITANIUM LOCKING SCREW WAS RETURNED. THE COMPLAINT DESCRIPTION STATED THAT THE SCREW HEAD POPPED OFF DURING DISTAL LOCKING OF THE TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE. THE SCREW HEAD WAS RETURNED SHEARED DIRECTLY BELOW THE HEAD AND THE NATURE OF THE BREAKAGE DOES NOT ALLOW FOR AN ACCURATE IDENTIFICATION OF THE SCREW FROM AN INSPECTION. THE COMPLAINANT IDENTIFIED THE SCREW AS A 5.0MM TI LOCKING SCREW WITH T25 STARDRIVE (PART 04.005.530S LOT 7840945 MANUFACTURE NOVEMBER 2014). THE COMPLAINT HAS BEEN DETERMINED TO BE CONFIRMED. THE RELEVANT PRODUCT DRAWING WAS REVIEWED DURING THE INVESTIGATION. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE RETURNED SCREW DID NOT HAVE A CE MARK, PART, OR LOT NUMBER ETCHED ON THE HEAD OF THE SCREW INDICATING THAT THE PART WAS MANUFACTURED IN THE US OR CANADA (AS CONFIRMED BY THE DEVICE HISTORY RECORD). THE DESIGN OF THE MEASURABLE PORTION OF THE SCREW WAS DETERMINED TO BE SUITABLE FOR THE INTENDED. 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. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT DESCRIPTION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION, HOWEVER BASED ON INSPECTION OF THE RETURNED PART IT IS POSSIBLE THAT THE DAMAGE WAS A RESULT OF EXPOSURE TO EXCESSIVE FORCES WHILE TIGHTENING THE SCREW. NO DESIGN ISSUES WERE NOTED DURING THE EVALUATION. 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 INITIALS ARE (B)(6). EXACT PATIENT WEIGHT IS UNKNOWN, BUT THE PATIENT IS REPORTEDLY OBESE. UDI NUMBER: (B)(4). IMPLANT AND EXPLANT DATES: THE DEVICE BROKE INTRA-OPERATIVELY AND IS NOT CONSIDERED TO BE IMPLANTED OR EXPLANTED. THE HEAD OF THE SCREW IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: NOVEMBER 10, 2014 - EXPIRATION DATE: SEPTEMBER 30, 2023. NO NON-CONFORMANCE REPORTS 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. THE STERILITY DOCUMENTATION WAS ALSO REVIEWED AND DETERMINED TO BE CONFORMING. 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 THE HEAD OF A DISTAL LOCKING SCREW POPPED OFF AS IT WAS BEING TIGHTENED INTO A TROCHANTERIC FIXATION NAIL (TFN) DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE RIGHT HIP ON (B)(6) 2015. THE SURGEON DECIDED NOT TO REMOVE THE SCREW SHAFT AS THE PATIENT WAS DETERMINED TO HAVE REALLY GOOD QUALITY OF BONE. THERE WAS A TWO (2) MINUTE SURGICAL DELAY WITH NO FURTHER PATIENT HARM REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788877 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER SCREW, FIXATION, BONE HWC SYNTHES MONUMENT 7840945

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention