BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMF SCREW Ø2 L8 SST

    MDR report key: 3072962 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01879
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832. THE FRACTURE FACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. NO PRODUCT FAULT COULD BE DETECTED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING THE REMOVAL, PAR EXAMPLE BY TOO MUCH LATERAL STRESS, CAUSED THIS BREAKAGE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2013, DURING A PROCEDURE, ONE IMF SCREW BROKE DURING REMOVAL. IT WAS REPORTED THAT FOUR SCREWS WERE INSERTED, AND THEY ALL FELT NORMAL. IT WAS REPORTED THAT A HOLDING SLEEVE WAS USED. AS SURGEON STARTED TO REMOVE ONE SCREW, IT SHEARED OFF, FLUSH WITH THE BONE. THE SURGEON LEFT THE RETAINED PART OF THE SCREW IS SITU IN PATIENTS BONE. IT WAS REPORTED THAT THE PLATE THAT WAS USED FOR THE PROCEDURE WAS NOT NEXT TO THE RETAINED FRAGMENT OF THE SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174437 IMF SCREW Ø2 L8 SST DZL SYNTHES GMBH 8261600

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR