BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM

    MDR report key: 3173805 · Received June 17, 2013

    Report

    Report Number
    1719045-2013-01637
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAVE BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE DEVICE WAS RECEIVED IN GOOD CONDITION. ORCHID UNIQUE MANUFACTURED THE MATRIX MIDFACE SCREWDRIVER. DUE TO AN UNKNOWN CAUSE THE BIT WILL HOLD THE SCREW. THE MATERIAL, DIAMETER AND TIP OF THE PRODUCT ARE DETERMINED TO BE WITHIN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A LEFORTE 1 OSTEOTOMY PROCEDURE ON (B)(6) 2013, SURGEON WAS USING A SCREWDRIVER BLADE FROM A MATRIX ORTHODONTIC SET. THE SCREWDRIVER BLADE WOULD NOT HOLD THE MAGNETIC POOL FOR HOLDING THE SCREWS, AND FELL INTO THE PATIENT'S MAXILLARY SINUS. X-RAY WAS TAKEN AND THE SCREW WAS REMOVED. THIS CAUSED A 20 MINUTE DELAY IN SURGERY. THE INCIDENT DID NOT EFFECT THE OUTCOME OF THE SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273333 MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM SCREWDRIVERS HXX SYNTHES MONUMENT U124417

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention