BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 4016390 · Received August 18, 2014

    Report

    Report Number
    2520274-2014-13176
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    June 13, 2014
    Report Date
    August 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZI
    PMA / PMN Number
    PK082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    AN UPDATED DEVICE HISTORY RECORD REVIEW WAS COMPLETED: REVIEW FROM MONUMENT FOR THE TIME AFTER THE PART WAS SHIPPED FROM SYNTHES (B)(4): DHR 03.505.004 - HANDLE FOR 90° SCREWDRIVER - LOT 8122253: SYNTHES (B)(4) MANUFACTURED THE PART. A NON-CONFORMANCE REPORT WAS ISSUED FOR PRODUCT MISSING BARCODE LABEL ON PACKAGE. THE LOT WAS RE-INSPECTED 100% AND ONE PIECE REWORKED TO PLACE THE LABEL. THE NON-CONFORMANCE REPORT WAS CLOSED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: NO VISIBLE DAMAGE. THE DEVICE WAS PRODUCED AND DISTRIBUTED IN SEPTEMBER 2012. ALL ITEMS ARE IN PERFECT WORKING ORDER. NO VISIBLE DAMAGE. UNFORTUNATELY WE WERE NOT ABLE TO REPRODUCE THE COMPLAINED ISSUE. THE DEVICE WORKS LIKE PER DESIGN INTENDED WHEN MOUNTED AS FORESEEN. THEREFORE IT IS LIKELY THAT THE INSTRUMENT WORKS CORRECTLY WHEN DISTRIBUTED. NO FURTHER INVESTIGATION NEEDED BECAUSE NO PRODUCT FAULT COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL MANUFACTURING DATE: MARCH 22, 2013. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: SYNTHES (B)(4) MANUFACTURED THE HANDLE FOR 90° SCREWDRIVER, PART 03.505.004, AND LOT 8122253. A NON-CONFORMANCE REPORT WAS ISSUED FOR PRODUCT MISSING BARCODE LABEL ON PACKAGE. THE LOT WAS RE-INSPECTED 100% AND 1 PIECE REWORKED TO PLACE THE LABEL; THE NON-CONFORMANCE REPORT WAS CLOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). ADDITIONAL COMMON DEVICE NAME: DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPON INSPECTION OF RETURNED DEVICE, IT WAS NOTED THAT THREE ADDITIONAL PARTS WERE RETURNED THAT WERE CONNECTED TO THE DRIVER SHAFTS. THIS IS REPORT 2 OF 7 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TWO SCREWDRIVERS BROKE DURING SURGERY, THE PARTS THAT BROKE WERE TWO HANDLES AND TWO SHAFTS. THE SURGEON WAS PERFORMING A MANDIBLE FRACTURE REPAIR PROCEDURE AND WHILE ATTEMPTING TO DRILL A HOLE, THE DEVICES WOULD NOT FUNCTION. THERE WAS A 15 MINUTE DELAY IN SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494363 HANDLE FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES MONUMENT 8122253

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR