BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEAR COVER FOR SCREWDRIVER 90°

    MDR report key: 4232146 · Received November 6, 2014

    Report

    Report Number
    8030965-2014-10621
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    June 13, 2014
    Report Date
    October 31, 2014
    Manufacturer
    SYNTHES OBERDORF
    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

    AN UPDATED DEVICE HISTORY RECORD REVIEW WAS COMPLETED: PART/LOT COMBINATION UNKNOWN AT SYNTHES (B)(4). LOT 8121636 WAS USED FOR THE PART 03.505.003, WHICH IS A SCREWDRIVER SHAFT. SO THE MANUFACTURING DOCUMENTS FOR PART 03.505.003 LOT 8121636 WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 MANUFACTURE DATE: JANUARY 29, 2013. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: SYNTHES (B)(4) MANUFACTURED THE SHAFT FOR 90° SCREWDRIVER. THE LOT WAS RECEIVED FROM SYNTHES (B)(4) AND RELEASED TO STOCK. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH NO VISIBLE DAMAGE; HOWEVER, THE ENTIRE GEAR AT THE SHAFT END IS MISSING. OUR INVESTIGATION SHOWS THAT THE ENTIRE GEAR AT THE SHAFT END IS MISSING. ALL OTHER ITEMS ARE IN PERFECT WORKING ORDER. NO VISIBLE DAMAGE. BASED ON THE RECEIVED INFORMATION WE CANNOT DETERMINE THE EXACT ROOT CAUSE. IT IS LIKELY THAT OVER TIGHTENING HAS LED TO THE DAMAGE OF THE GEAR AND TO THE MALFUNCTION OF THE DEVICE. THEREFORE THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FIND TO BE WITHIN SPECIFICATIONS. WE WERE NOT ABLE TO REPRODUCE THE COMPLAINED ISSUE. THE DEVICE WORKS LIKE PER DESIGN INTENDED WHEN MOUNTED AS FORESEEN. IT IS LIKELY THAT THE INSTRUMENT WORKS CORRECTLY WHEN DISTRIBUTED. NO FURTHER INVESTIGATION NEEDED BECAUSE NO PRODUCT FAULT COULD BE DETECTED; THE DAMAGE WAS CLEARLY CAUSED POST MANUFACTURING. 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

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713277 GEAR COVER FOR SCREWDRIVER 90° DRILL, BONE, POWERED DZI SYNTHES OBERDORF 8121636

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR