BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 3031808 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10665
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PRODUCT DEVELOPMENT EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED WITH THE ARM OF THE DEVICE BROKEN CLOSE TO THE HINGE AT THE JUNCTION WHERE THE ARM AND FLAT FACE INTERSECT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS ISSUE WAS PREVIOUSLY EVALUATED AND DEEMED VALID. A CAPA RISK ASSESSMENT WAS COMPLETED. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WAS NOT INITIATED. A DESIGN CHANGE WAS IMPLEMENTED AFTER MANUFACTURING DATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN MTP (METATARSOPHALANGEAL) FUSION, THE ARM ON A PAIR OF COMPRESSION FORCEPS BROKE OFF. THE SURGEON USED A DIFFERENT METHOD TO ACHIEVE COMPRESSION. THE BROKEN PART WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134256 COMPRESSION FORCEPS HWN SYNTHES GMBH T949329

    Patients

    Seq Age Sex Outcome Treatment
    1