BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S

    MDR report key: 2981726 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-006667
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE COMPLAINT ARTICLE WAS FORWARDED FOR INVESTIGATION TO (B)(4). THE INVESTIGATION HAS SHOWN THAT THE TIP IS BROKEN. AFTER INVESTIGATION A NEW PART WAS RETURNED DIRECTLY TO THE COUNTRY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE SAW BLADE BROKE DURING SURGERY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84481 SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S SAW BLADE GFA SYNTHES GMBH 837352

    Patients

    Seq Age Sex Outcome Treatment
    1