BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.7X14MM, (5/PACKAGE)

    MDR report key: 3790050 · Received May 5, 2014

    Report

    Report Number
    0008010177-2014-00117
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER LEIBINGER-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE SCREW BROKE COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED EVENT WAS ATTRIBUTED TO A USER RELATED ISSUE. THE SURFACE OF THE FRACTURE INDICATES THAT THE BREAKAGE OCCURRED DUE TO A GREAT FORCE. THE FRACTURE SURFACE IS SHOWN ON FIGURE 3+4 OF THE IMAGE DOCUMENTARY REPORT. IN THE OP-TECH. FOR VARIAX DISTAL RADIUS LOCKING PLATE SYSTEM IS STATED: ¿IN HARD, CORTICAL BONE A 2.3MM CORTICAL DRILL BIT (60-23341) OR THE 2.7MM TAP (62-27010) MAY BE USED TO INSERT THE 2.7MM SCREW TO HELP REDUCE THE RISK OF SCREW BREAKAGE DURING INSERTION.¿ [ORIGINAL STATEMENT] TO PERFORM FINAL TIGHTENING BY HAND IS RECOMMENDED. TO AVOID DAMAGE TO THE SCREW WHILE INSERTING IN DENSE BONE, TAPPING A THREAD CAN BE AN ADVANTAGE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE SCREW POPPED OFF WHEN THE SURGEON WAS IMPLANTING IT MANUALLY DURING A PRIMARY TRAUMA SURGERY. THE SCREW TIP REMAINED IMPLANTED IN THE PATIENT BUT IS IMPLANTED DEEP ENOUGH INTO THE DISTAL RADIUS SO HE FORESEES NO ISSUE. THE SURGEON USED ANOTHER SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE SCREW POPPED OFF WHEN THE SURGEON WAS IMPLANTING IT MANUALLY DURING A PRIMARY TRAUMA SURGERY. THE SCREW TIP REMAINED IMPLANTED IN THE PATIENT BUT IS IMPLANTED DEEP ENOUGH INTO THE DISTAL RADIUS SO HE FORESEES NO ISSUE. THE SURGEON USED ANOTHER SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269371 BONE SCREWS, CROSS-PIN, DIAM.2.7X14MM, (5/PACKAGE) PLATE, FIXATION, BONE HRS STRYKER LEIBINGER-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other