BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACT-SCREW CONI F/SCR Ø4.5+6.5

    MDR report key: 2873471 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01575
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED EXTRACTION SCREW SHOWS THAT THE. TIP IS BROKEN DUE TO MECHANICAL OVERLOADING DURING USE. EXCEEDING APPLIED MECHANICAL FORCE, WELL BEYOND ITS CALCULATED DESIGN MAY HAVE CAUSED THE BREAKAGE. WE ASSUME THAT THE LOCKING SCREW WAS COMPLETELY BLOCKED INSIDE THE LOCKING THREAD. MAY BE TOO STRONG TIGHTENING DURING INSERTION OR SOME INFLUENCE DURING HEALING PROCESS CAUSED FRETTING OF THE SCREW IN THE PLATE. THEREFORE A TOO HIGH MECHANICAL FORCE WAS APPLIED WHILE TRYING TO REMOVE THEM. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A PROCEDURE FOR A DISTAL RADIUS FRACTURE THE SURGEON WAS ATTEMPTING TO REMOVE A SCREW IN ORDER TO REMOVE A PLATE AND HE STRIPPED THE HEX RECESS OF THE SCREW. THE SURGEON USED THE EXTRACTION SCREW TO REMOVE THE STRIPPED SCREW AND THE TIP OF THE EXTRACTION SCREW BROKE OFF. THE TIP OF THE EXTRACTION SCREW WAS LEFT IN THE BODY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACT-SCREW CONI F/SCR Ø4.5+6.5 EXTRACT-SCREW CONI F/SCR Ø4.5+6.5 HWC SYNTHES GMBH 7719504

    Patients

    Seq Age Sex Outcome Treatment
    1