BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 3083451 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10972
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION NOTED THAT THE CONICAL EXTRACTION SCREW WAS RETURNED WITH THE TIP BROKEN OFF, ONLY APPROXIMATELY 16MM (FROM THE TOTAL OF 19MM) OF THE TIP REMAINED. PART SHOWS BURRS AT THE BREAK SITE BUT DOESN'T EXHIBIT ANY UNUSUAL WEAR OR COSMETIC DAMAGE. DAMAGE IS NOT CONSISTENT WITH MANUFACTURING OR INSPECTION PROCESSES. THE CONICAL EXTRACTION SCREW MET SPECIFICATIONS. THE ROOT CAUSE OF THE DAMAGE IS UNKNOWN. PRODUCT DEVELOPMENT EVALUATION NOTED THAT THE DEVICE WAS MISSING THE TIP OF THE THREADED END FROM WHAT LOOKS TO BE A FAILURE FROM AXIAL TENSION. NO OTHER NON-CONFORMANCES OR MARKINGS OF MISUSE ARE EVIDENT. BASED ON THE INSPECTION REPORT FROM THE VENDOR, ALL FEATURES WERE FOUND TO BE IN SPECIFICATIONS. THE COMPLAINT MENTIONED USE IN THE ANKLE, WHICH IS AN OFF-LABEL USE FOR THIS PRODUCT. THE INSTRUMENT IS MEANT TO BE USED WITH THE CSLP SYSTEM IN THE ANTERIOR CERVICAL SPINE. THE RISK ASSESSMENT DOES NOT ANTICIPATE THE USE IN ANKLES OR THE TYPE OF BONE DENSITY OR ANGULATIONS ASSOCIATED WITH THE PROCEDURE. BASED ON THE INFORMATION GIVEN, THE DEVICE FAILED IN AN OFF-LABEL USE OF THE PRODUCT. FOR THIS REASON, THE COMPLAINT WILL BE CONSIDERED INVALID FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    THIS WAS A HARDWARE REMOVAL FROM ANKLE. PATIENT RETURNED TO SURGEON COMPLAINING OF PAIN. HARDWARE WAS REPORTEDLY INTACT, FRACTURE REPORTEDLY FUSED. THE SURGEON DID NOT IMPLANT ANY OTHER HARDWARE. CONICAL EXTRACTION SCREW TIP BROKE WHILE REMOVING HARDWARE. ORIGINAL IMPLANT DATE IS UNKNOWN. IMPLANTS WERE DISPOSED OR GIVEN TO PATIENT. CONSULTANT INFORMED US THE HOSPITAL JUST GAVE HIM AN EXTRACTION SCREW WITH THE CORTEX SCREW STILL IN THE DEVICE. HE REPORTED IT WAS NOT AN EXTRACTION BOLT. ALL PARTS THAT HAVE THE EXTRACTION BOLT NUMBER HAVE TO BE CHANGED BACK TO UNKNOWN CORTEX SCREWS. THIS IS 1 OF 7 REPORT FOR EVENT #(B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185720 CONICAL EXTRACTION SCREW FSM SYNTHES MONUMENT U100633

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR