BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVESHAFT FOR SCREWDRIVER 90°

    MDR report key: 4232145 · Received November 6, 2014

    Report

    Report Number
    8030965-2014-10620
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    June 13, 2014
    Report Date
    October 31, 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

    AN UPDATED DEVICE HISTORY RECORD REVIEW WAS COMPLETED: PART/LOT COMBINATION UNKNOWN AT SYNTHES (B)(4). LOT 8062742 WAS USED FOR THE PART 50162637, WHICH IS A SUB-COMPONENT (COVER) OF THE SCREWDRIVER 03.505.003. THIS SUB-COMPONENT WAS SHIPPED DIRECTLY TO THE USA BACK THEN. THE MANUFACTURING DOCUMENTS OF THE COVER 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

    LOT NUMBER 8062742 REPORTED FOR THE SUBJECT DEVICE CORRESPONDS TO DEVICE PART NUMBER 03.505.003 (SHAFT FOR 90° SCREWDRIVER). ADDITIONAL INFORMATION AND CLARIFICATION PROVIDED BY SYNTHES ENGINEERING ON JAN 15, 2015 REVEALED ALTHOUGH THIS LOT NUMBER CORRESPONDS TO THE SHAFT, DRIVESHAFT (SUBJECT DEVICE, PART NUMBER 03.505.606) IS SOLD IN TANDEM WITH THE SHAFT AND THEREFORE, THE DEVICE HISTORY RECORDS AND OTHER EVALUATIONS FOR THE SHAFT PART WOULD BE RELEVANT TO THE SUBJECT DEVICE DRIVESHAFT AS WELL. A MANUFACTURING EVALUATION WAS PERFORMED FOR THE RETURNED HANDLES, SCREWDRIVER SHAFTS, AND DRIVESHAFTS. TWO 90° SCREWDRIVER SHAFTS WERE RETURNED (PART # 03.505.003, LOT# 8121636) WITH THE COMPLAINT THAT THEY BROKE DURING A MANDIBLE FRACTURE REPAIR PROCEDURE. UPON RECEIPT OF THESE DEVICES IT WAS SEEN THAT THE DRIVER SHAFTS EASILY ROTATED AND FUNCTION AS INTENDED, ONE OF THESE DRIVESHAFTS WAS RETURNED WITH THE GEAR COVER ATTACHED, BOTH OF THESE WERE RETURNED WITH THE DRIVESHAFT FOR 90° SCREWDRIVER (PART 03.505.006, LOT # 8121636 AND LOT 8062742 [SUBJECT DEVICE]) ATTACHED. TWO HANDLES FOR 90° SCREWDRIVERS WERE RETURNED, PART 03.505.004 LOT 8122253. THE INTERNAL ASPECT OF ONE OF THESE WAS FOUND TO ROTATE EASILY AND SMOOTHLY, THE OTHER IS RESISTANT TO ROTATION. NONE OF THE RETURNED PARTS WERE FOUND TO BE BROKEN; ONE OF THE HANDLES HOWEVER, FUNCTIONS AT A SUBOPTIMAL LEVEL. MANUFACTURING EVALUATIONS WERE PERFORMED ON THESE DEVICES. IT WAS FOUND THAT OF THESE PARTS, ONE OF THE HANDLES FOR 90° SCREWDRIVERS WAS FOUND TO HAVE ROUGH-RUNNING MOVABLE PARTS BUT NO VISIBLE DAMAGE AND LIKELY WAS OVER TIGHTENED POST MANUFACTURING. ALL SIX OF THE REMAINING DEVICES WERE FOUND TO BE IN PERFECT WORKING ORDER WITH NO VISIBLE DAMAGE. THE ROOT CAUSE COULD NOT BE DETERMINED AS NONE OF THE RETURNED PARTS WERE FOUND TO BE BROKEN; ONE OF THE HANDLES HOWEVER, FUNCTIONS AT A SUBOPTIMAL LEVEL AND LIKELY RESULTED FROM OVER-TIGHTENING. FOR SIX OF THE PARTS NO PRODUCT FAULT COULD BE DETECTED, FOR THE HANDLE WHICH STICKS, THIS IS LIKELY THE CAUSE OF OVER-TIGHTENING POST MANUFACTURING. A DEVICE HISTORY REVIEW HAS BEEN REQUESTED. 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 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712824 DRIVESHAFT FOR SCREWDRIVER 90° DRILL, BONE, POWERED DZI SYNTHES MONUMENT 8062742

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR