BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 3928515 · Received July 11, 2014

    Report

    Report Number
    2520274-2014-12511
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 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

    (B)(6). THIS REPORT IS FOR AN UNKNOWN DRILL BIT/UNKNOWN LOT. 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. 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: AN UPDATED DEVICE HISTORY RECORD REVIEW WAS COMPLETED: REVIEW FROM MONUMENT FOR THE TIME AFTER THE PART WAS SHIPPED FROM SYNTHES (B)(4): DHR 03.505.003 - SHAFT FOR 90° SCREWDRIVER - LOT 8121636: SYNTHES (B)(4) MANUFACTURED THE PART. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    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

    THIS COMPLAINT DESCRIPTION HAS BEEN UPDATED WITH CORRECTED INFORMATION SINCE THE INITIAL REPORT WAS SUBMITTED TO THE FDA. IT WAS ORIGINALLY REPORTED THAT A SCREWDRIVER AND A DRILL BROKE DURING SURGERY. ALL ADDITIONAL INFORMATION AND CORRECTIONS TO THE INITIAL REPORT ARE WITHIN THIS REPORT.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: JANUARY 29, 2013. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: SYNTHES (B)(4) MANUFACTURED THE SHAFT FOR 90° SCREWDRIVER, PART 03.505.003, AND LOT 8121636. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. A MANUFACTURING EVALUATION WAS COMPLETED: THE ENTIRE GEAR AT THE SHAFT END IS MISSING. THE DEVICE WAS PRODUCED AND DISTRIBUTED IN JULY 2012. 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. THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FIND TO BE WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION NEEDED BECAUSE 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

    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

    IT WAS REPORTED THAT A SCREWDRIVER AND DRILL BROKE DURING SURGERY. THE SURGEON WAS PERFORMING A MANDIBLE FRACTURE REPAIR PROCEDURE AND WHILE ATTEMPTING TO DRILL A HOLE, THE DEVICE WOULD NOT FUNCTION. THERE WAS A FIFTEEN MINUTE DELAY IN SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THIS REPORT IS FOR AN UNKNOWN DRILL BIT. THIS IS REPORT 2 OF 2 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(B)(4)

    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 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407606 SHAFT FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES MONUMENT 8121636

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR