BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/SCREW GUIDE

    MDR report key: 2931317 · Received January 28, 2013

    Report

    Report Number
    8030965-2013-00239
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ONE PIN IS BROKEN OFF AND THE BROKEN FRAGMENT IS MISSING. THE OTHER PIN IS BENT OUTWARD AND THE TIP IS PARTIALLY FLATTENED. WITHOUT THE FRAGMENT OF THE BROKEN PIN THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANY MORE. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY, AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THIS AND THE ABOVE MENTIONED DAMAGES OF THE EXISTING LET US ASSUME THAT A MECHANICAL OVERLOAD DURING USE IN COMBINATION WITH TOO MUCH LATERAL STRESS MAY HAVE CAUSED THIS OCCURRENCE. THE DRILL/SCREW GUIDE IS A PART OF THE ANTEGRA SYSTEM. THE INSTRUMENT HAS 3 COMPONENTS ALL MADE OF (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT; NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INITIALS, AGE, DOB AND GENDER NOT PREVIOUSLY REPORTED. CONSULTANT REPORTED HOSPITAL CONFIRMED SURGERY DATE AS (B)(6) 2013 AND PATIENTS INITIALS AS (B)(6).

    Description of Event or Problem · 1

    DURING A L4-L5 ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE SURGEON INSERTED THE DRILL/SCREW GUIDE INTO THE VERTEBRAL BONE SEGMENT. SUBSEQUENTLY, THE GUIDE PIN BROKE FROM THE DEVICE AND REMAINED IMPLANTED IN THE PATIENT. A SECOND DRILL/SCREW GUIDE WAS USED FOR A SEPARATE PORTION OF THE VERTEBRAL SEGMENT IN WHICH THE GUIDE PIN HAD ALSO BROKE AND REMAINED IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 : ADDITIONAL INFORMATION CONFIRMED BY (B)(4) DATED (B)(4) 2013: (B)(6) REPORTED HE PERSONALLY MET WITH (B)(6), MATERIALS MANAGER (B)(6) HOSPITAL ON (B)(6) 2103. (B)(6) (THE INITIAL REPORTER) CONFIRMED THE PROCEDURE OCCURRED ON (B)(6) 2013 AND THAT THE PATIENTS INITIALS WERE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36920 DRILL/SCREW GUIDE DRILL/SCREW GUIDE FZX SYNTHES GMBH 3455265

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR DRILL/SCREW GUIDE