BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED PELVIC OSTEOTOME 20MM WIDTH

    MDR report key: 3544812 · Received December 31, 2013

    Report

    Report Number
    8030965-2013-05687
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 6, 2013
    Report Date
    December 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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 HAVE BEEN REQUESTED DHR: REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #2122420 IS CORRESPONDING TO THE SPECIFICATIONS. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT DEVELOPMENT EVALUATION: THE REPORTED PART WAS RECEIVED IN A PARTIALLY-REASSEMBLED STATE; THEREFORE, IT CANNOT BE DETERMINED IF THE DESIGN IS ADEQUATE FOR THE INTENDED USE. THE RESULT OF THIS EVALUATION IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION: THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE HARDNESS WAS REMEASURED AND FOUND TO BE CONFORMING AT 52,3 HRC. ALL PARTS WEREN'T RETURNED SO WE CANT PERFORM A FULL INVESTIGATION AND CONCLUDE THIS COMPLAINT TO BE INDETERMINATE.

    Description of Event or Problem · 1

    DURING A HIP PERIACETABULAR OSTEOTOMY PROCEDURE, THE PIN OF A CURVED PELVIC OSTEOTOMY CHISEL FELL OUT CAUSING THE HANDLE TO SEPARATE AS THE SURGEON FINISHED USING IT FOR THE SURGERY. THE PATIENT INFORMATION WAS UNAVAILABLE. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS REPORTED AS FINE. THIS IS REPORT ONE OF ONE FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682699 CURVED PELVIC OSTEOTOME 20MM WIDTH HWM SYNTHES GMBH T987867

    Patients

    Seq Age Sex Outcome Treatment
    1