BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRA 1/2 SIZER/11MM

    MDR report key: 3130015 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02818
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE SIZER WAS RECEIVED WITH SEVERAL SCRATCHES ALONG THE SURFACE OF THE SHAFT. THERE IS A SMALL CHIP OFF THE BACK OF THE HANDLE. THE SIZER IS USED IN ANTERIOR LUMBAR FUSION PROCEDURES TO DETERMINE THE CORRECT HEIGHT OF THE FRA SPACERS. THE SIZER HANDLE HAS A CHIP OF MATERIAL MISSING ON THE BACK END OF THE HANDLE. THE CHIP IS APPROXIMATELY 9MM IN LENGTH. THIS SIZER WAS RECEIVED FROM SERVICE AND REPAIR AND THERE IS NO INFORMATION AS TO HOW OR WHEN THIS CHIP OCCURRED. THE DAMAGE TO THE HANDLE DOES NOT AFFECT THE FUNCTION OF THE DEVICE. THE LOT A7HA21 WAS RECEIVED IN MAY 1998 AND HAS BEEN IN EXISTENCE FOR OVER 15 YEARS. THE DAMAGE TO THE INSTRUMENT MOST LIKELY IS FROM A LONG PERIOD OF USE AND A SPECIFIC CAUSE COULD NOT BE DETERMINED. THE CAUSE OF DAMAGE TO THE INSTRUMENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED IN THE COMPLAINT DESCRIPTION (SERVICE AND REPAIR). AN ADDITIONAL EVALUATION WAS ALSO CONDUCTED. THIS REPORT INDICATES THE ITEM WAS RECEIVED IN FAIR CONDITION. THE HANDLE SHOWED SIGNS OF WEAR DUE TO ITS ADVANCED AGE. THERE IS A SMALL GOUGE NEAR THE METAL NEAR THE TIP OF THE TRIAL. THERE IS A SMALL MISSING CHIP IN THE HANDLE NEAR THE TOP EDGE. NO VISIBLE DROP DAMAGE ON THE HANDLE. THE ITEM WAS RELEASED TO THE WAREHOUSE 06/10/1998. DUE THE ITEMS AGE THE HANDLE HAD BECOME WORN DUE TO PROLONGED USE. THERE ARE NO KNOWN NCRS ASSOCIATED WITH THIS ITEM NUMBER/LOT NUMBER. A DHR REVIEW IS NOT POSSIBLE AS THE DEVICE IS OVER 15 YEARS OLD AND THERE IS NO DHR AVAILABLE LOT NUMBER CORRECTED FROM X47HA21 TO A7HA21.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. LOT NUMBER XA7HA21 DOES NOT HAVE A SYNTHES CROSS-REFERENCE LOT NUMBER FOR PART NUMBER 397.016; THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4): THE ITEM WAS RECEIVED WITH THE TIP OF THE HANDLE CHIPPED OFF. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.DEVICE IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT.CHANGED PRODUCT CODE FROM LXH TO HWT.(B)(4)

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE TIP OF THE HANDLE CHIPPED OFF AND THIS DID NOT HAPPEN DURING A CASE. THE COMPLAINT WAS FOR A WARRANTY REPLACEMENT ONLY. THE EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THE REPORTED INSTANCE WAS NOT AN ANTICIPATED SERVICE OR WARRANTY REPLACEMENT ISSUE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231203 FRA 1/2 SIZER/11MM HWT SYNTHES USA A7HA21

    Patients

    Seq Age Sex Outcome Treatment
    1