BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM

    MDR report key: 3674553 · Received March 12, 2014

    Report

    Report Number
    3003875359-2014-10018
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS AN INSTRUMENT, CANNOT BE IMPLANTED OR EXPLANTED. A REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. 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

    THE RETURNED DEVICE WAS EVALUATED BY ENGINEER AND THE REPORT STATES THAT THE RETURNED STARDRIVE SCREWDRIVER SHAFTS T4/66MM (PART #03.114.009, LOT#3455669 & 03.114.002, LOT#6193592) WERE RETURNED FOR EVALUATION WITH COMPLAINT CATEGORY OF "DOES NOT FIT WITH OTHER PARTS". THE DISTAL STARDRIVE TIP OF THE RETURNED SCREWDRIVER SHAFTS ARE SIGNIFICANTLY WORN AND SLIGHTLY TWISTED IN THE DIRECTION OF TIGHTENING A SCREW. THIS CONDITION HAS AFFECTED THE TIP IN A DIMENSIONAL WAY WHICH PREVENTS IT FROM FITTING INTO THE INTENDED SCREW'S DRIVE FEATURE. THE SHAFT IS MADE FROM CUSTOM 465 STAINLESS STEEL, WHICH IS A STANDARD MATERIAL FOR SYNTHES SCREWDRIVER SHAFTS AND ADEQUATE FOR THIS APPLICATION. THE SET USING THESE SCREWDRIVER SHAFTS IS THE 1.5 MM LCP MINI FRAG SYSTEM. THE SCREWDRIVER IS INTENDED TO INSERT THE 1.5 MM SCREWS AND, DUE TO THE LOW TORQUE REQUIRED TO INSERT THE SCREWS, IS ADEQUATE FOR THE INTENDED USE AND NO TORQUE LIMITING ATTACHMENT IS REQUIRED. THE TWISTING NOTED ON THE TIP OF THE RETURNED DEVICE IS INDICATIVE THAT IT HAS BEEN SUBJECTED TO TORQUE SIGNIFICANTLY BEYOND THAT REQUIRED TO INSERT THE 1.5 MM SCREWS. THE CONDITION OF THE RETURNED DEVICE INDICATES THAT TORQUE IN EXCESS OF THAT REQUIRED FOR ITS INTENDED USE WAS APPLIED AND CAUSED THE COMPLAINT CONDITION. THE DESIGN WAS EVALUATED AND DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE. THE COMPLAINT CONDITION IS HOWEVER CONFIRMED FOR "DOES NOT FIT WITH OTHER PARTS" DUE TO THE TWISTED AND WORN CONDITION OF THE DEVICES WHICH IS NOT DETERMINED TO BE THE RESULT OF A DEVICE DESIGN DEFICIENCY. 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. ADDITIONAL NARRATIVE: REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) FOR PART NUMBER (P/N) 03.114.009, LOT 6461116, SHOWED A REWORK RELATED TO REWORK THE 03.114.009.1 COMPONENT. THE 03.114.009 ASSEMBLY WAS DISASSEMBLED, AND THE 03.114.009.1 COMPONENTS WERE RETURNED TO SYNTHES (B)(4) FOR REWORK. ONCE THE REWORK WAS COMPLETED, THE PARTS WERE REASSEMBLED. REVIEW OF THE COMPONENT DHR FOR P/N 03.114.010, LOT 6365879, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE COMPONENT DHR FOR P/N 03.114.010, LOT 6365881, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE COMPONENT DHR FOR P/N 03.114.009.1, LOT 3455669, SHOWED NCR (B)(4) GENERATED FOR BENT GRIPPING JAWS AND WAS PART OF STOCK EVALUATION (B)(4). THE PARTS WERE RETURNED TO SYNTHES (B)(4) FOR REWORK. REVIEW OF THE DHRS SHOWED THAT THERE WERE ISSUES DURING THE MANUFACTURE OF THE PRODUCT. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. THE ORIGINAL LOT NUMBER REPORTED AS 3455669 WAS INCORRECT THE LOT NUMBER WAS AN ASSEMBLY PART THEREFORE THE DHR INITIALLY REPORTED WAS ALSO INCORRECT INFORMATION 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

    DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A METACARPAL, THE SURGEON HAD TWO SCREWDRIVERS NOT ABLE TO ENGAGE WITH TWO SEPARATE SCREW HEADS. AFTER REVIEWING THE SITUATION WITH THE SURGEON AND DISCUSSING WITH PRODUCT DEVELOPMENT THEY DETERMINED THE SCREW DRIVER SHAFTS TO BE STRIPPED. THE SCREWS WERE BOTH SUCCESSFULLY TIGHTENED. NO IMPACT TO THE PATIENT. THE SURGERY WAS DELAYED FOR LESS THAN 15 MINUTES DUE TO THE EVENT. THIS IS REPORT 2 OF 3 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146995 STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM SCREWDRIVER HXX SYNTHES MONUMENT 6461116

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR