BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 3034677 · Received April 4, 2013

    Report

    Report Number
    1719045-2013-10570
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE TIP OF THE EXTRACTION SCREW INNER SHAFT IS BROKEN AND THE END IS MISSING AS DESCRIBED IN THE COMPLAINT. THE MISSING PIECE WAS NOT RETURNED. THERE IS CORROSION IN AND AROUND THE ETCHING FOR BOTH, THE PART NUMBER AND LOT NUMBER ON THE OUTER SLEEVE, A SPOT ON THE KNURLED PORTION OF THE OUTER SLEEVE AND SOME MINOR DISCOLORATION ON THE METAL END OF THE HANDLE. THESE DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE MATERIAL OF THE INTERNAL SHAFT OF THE EXTRACTION SCREW WAS CHANGED FROM 440A TO 465 TO ADDRESS THIS FAILURE MODE AS A RESULT OF AN INTERNAL CORRECTIVE ACTION. THE CHANGE WAS MADE EFFECTIVE ON 3/29/07. SINCE THIS LOT, 5051794 (SUPPLIER LOT 555359G05) WAS MANUFACTURED PRIOR TO THE CHANGE AND BASED ON THE MEMO REFERENCED ABOVE, NO FURTHER EVALUATION IS NEEDED. THIS ISSUE HAS BEEN ADDRESSED BY A PREVIOUS CORRECTIVE ACTION AND THE LOT ON THIS COMPLAINT (B)(4) WAS PRODUCED BEFORE THE MATERIAL CHANGE BECAME EFFECTIVE. SINCE THE DETAILS OF HOW THE DEVICE WAS USED ARE NOT AVAILABLE AND THE TIP WAS NOT RETURNED, THE COMPLAINT IS DEEMED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A VECTRA PLATE AT C4-C6 ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2011 FOR ADJACENT LEVEL FUSION AT C3. DURING REMOVAL OF THE EXISTING VECTRA PLATE, THE TIP OF THE EXTRACTION SCREWDRIVER BROKE OFF IN THE HEAD OF A SCREW. THE TIP WAS RETRIEVED AND SURGEON USED ANOTHER SCREWDRIVER TO REMOVE THE SCREWS AND THE PLATE. THE SURGEON COULD NOT GET A ZERO-P IN AND OPTED TO USE ANOTHER VECTRA PLATE FROM C3-C6 TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139490 EXTRACTION SCREWDRIVER HXX SYNTHES MONUMENT 555359G05

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR