BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PL HOLDING TIP F/ARTICULATING PLATE INTRODUCER (386.900)

    MDR report key: 3070504 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10837
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE LOT NUMBER WAS NOT PROVIDED WITH THIS COMPLAINT, SO NO REVIEW OF THE INCOMING INSPECTION DATA OR MATERIAL CERTIFICATIONS FROM THE VENDOR WERE AVAILABLE TO REVIEW. MANUFACTURING EVALUATION REPORTS THAT THE PART WAS RECEIVED AND THERE WAS NO APPARENT DAMAGE TO IT OTHER THAN THE RETAINING FASTENER BEING SEPARATED FROM THE PLATE HOLDING TIP DETAIL. ALL INSPECTIONS WERE MADE TO THE CURRENT DRAWING, SINCE THERE WAS NO LOT NUMBER TO VERIFY WHICH REVISION THE PARTS WERE MADE TO. THE HOLE DIAMETER OF THE PLATE HOLDING TIP DETAIL WAS SLIGHTLY UNDERSIZED PER (B)(4). THE RETAINING FASTENER WAS SLIGHTLY UNDERSIZED PER (B)(4). THESE FEATURES WOULD NOT HAVE BEEN ABLE TO BE INSPECTED AS THE PRODUCT IS SUPPLIED AS AN ASSEMBLY. BASED ON THE UNKNOWN ORIGINAL MANUFACTURING CONDITION, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    DURING A MANDIBLE FRACTURE REPAIR, AS THE SURGEON WAS USING THE PLATE HOLDER WITH THE TIP, THE TIP BROKE AND SEPARATED. THE SURGEON USED A SPARE TIP TO COMPLETE THE PROCEDURE. ALL PIECES WERE RETRIEVED AND THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171509 PL HOLDING TIP F/ARTICULATING PLATE INTRODUCER (386.900) FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR