BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FORQUICK LOCK SCREWS 275MM

    MDR report key: 3082674 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10960
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. THE DRIVER SHOWS TWO MISSING FLANGES AND TWO FLANGES THAT HAVE BEEN BADLY DEFORMED. THE REMAINING FLANGES ARE SPLAYED IN THE COUNTER CLOCKWISE DIRECTION. ALL OTHER ASPECTS OF THE DRIVER APPEAR TO BE IN GOOD CONDITION, AND THE DRIVER LOOKS TO BE WITHIN THE DESIGN SPECIFICATIONS. IT CANNOT BE DETERMINED WHAT THE EXACT CAUSE OF THE INCIDENT WAS, THEREFORE THE COMPLAINT WILL BE CONSIDERED INDETERMINATE FROM A DESIGN STANDPOINT. BASED ON THE EVALUATION PERFORMED AND ON THE FACT THAT THE PARTS DID NOT MEET PRINT SPECIFICATIONS BEFORE IT WAS SHIPPED TO SYNTHES, THIS COMPLAINT IS DEEMED VALID FROM A MANUFACTURING POSITION. THE PART RETURNED ONLY HAS TWO REMAINING PRONGS THAT ARE BENT FROM THE ORIGINAL MANUFACTURED CONDITION. THERE IS AN AREA THAT LOOKS LIKE A V WHERE MATERIAL IS MISSING FROM THE TIP END OF THE SCREWDRIVER TIP WHERE ONE OF THE PRONGS THAT BROKE OFF IS MISSING ON THE TIP OF THE SCREWDRIVER. THE REMAINING ASSEMBLY APPEARS TO BE AS ASSEMBLED AND MEETING THE ASSEMBLY PRINT REQUIREMENTS. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACDF C5-C6, C6-C7 AS THE SURGEON WAS TRYING TO ADVANCE A SCREW, TWO OF THE SCREWDRIVER PRONGS BROKE OFF INTO THE WOUND. FRAGMENTS WERE RETRIEVED AND ACCOUNTED FOR. THE SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184448 SELF-RETAINING SCREWDRIVER FORQUICK LOCK SCREWS 275MM HXX SYNTHES MONUMENT 6672832

    Patients

    Seq Age Sex Outcome Treatment
    1