BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 20MM

    MDR report key: 3022543 · Received March 27, 2013

    Report

    Report Number
    1719045-2013-00741
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4). THE PACKAGING, LABELING, AND STERILIZATION ARE PER SYNTHES STANDARDS, AND A TECHNIQUE GUIDE EXISTS TO EXPLAIN PROPER IMPLANTATION OF THE SYSTEM. NO OTHER DESIGN ASPECT COULD HAVE CONTRIBUTED TO A FAILURE SUCH AS THIS. AN EXACT CAUSE OF THIS COMPLAINT CAN NOT BE DETERMINED: IT IS UNKNOWN IF THE CORRECT INSTRUMENTATION WAS USED, IF THE CORRECT PROCEDURE WAS FOLLOWED, AND WE DO NOT HAVE ANY POST-OPERATIVE DATA ON THE PATIENT. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS SCREW IS WHOLE AND INTACT. IT HAS BEEN CONFIRMED AS BEING A 02.210.120. THE DRIVE HAS BEEN MODERATELY DAMAGED, PRIMARILY AT THE TOP PORTION OF THE DRIVE. THE TOP OF THE HEAD HAS ALSO BEEN MODERATELY DAMAGED WITH MULTIPLE IMPACT MARKS AND METAL DEFORMATION. THE HEAD THREADS HAVE BEEN COMPRESSED AT THE MAJOR DIAMETER, PARTICULARLY NEAR THE TOP OF THE HEAD. THERE ARE TWO INDENTATIONS TRAVERSING THE HEAD THREADS. THE FIRST TEN SHAFT THREADS HAVE BEEN DAMAGED WITH IMPACT/COMPRESSION TYPE DAMAGE. THE REMAINDER OF THE SHAFT THREADS IS IN GOOD CONDITION, AS ARE THE FLUTES AND TIP. THE DEVICE COULD NOT BE MEASURED DUE TO DAMAGE INCURRED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT DEVELOPMENT EVENT EVALUATION: THE LOCKING SCREWS ARE DESIGNED TO BE MANUFACTURED OF IMPLANT GRADE (B)(4) STAINLESS STEEL PER (B)(4). THE SCREW HEADS ARE DESIGNED WITH CORRECT MATING DIMENSIONS TO THE PLATE HOLES ((B)(4)). THE PACKAGING, LABELING, AND STERILIZATION ARE PER SYNTHES STANDARDS, AND A TECHNIQUE GUIDE EXISTS TO EXPLAIN PROPER IMPLANTATION OF THE SYSTEM. NO OTHER DESIGN ASPECT COULD HAVE CONTRIBUTED TO A FAILURE SUCH AS THIS. SINCE IT IS UNKNOWN IF THE CORRECT INSTRUMENTATION WAS USED, IF THE CORRECT PROCEDURE WAS FOLLOWED, AND WE DO NOT HAVE ANY POST-OPERATIVE DATA ON THE PATIENT, THIS COMPLAINED IS DEEMED INDETERMINATE. WE RECEIVED 3 SCREWS BACK FOR THE CUSTOMER. THE COMPLAINT STATES ¿THE MOST DISTAL AND RADIAL LOCKING SCREW HAD BACKED OUT OF PLATE,¿ ALTHOUGH WE DO NOT KNOW WHICH ONE IT WAS. WE HAVE ALL IF THE PART NUMBERS: ENTERED 3 PARTS INTO THE PART DATA AS, UNK-LOCKING SCREW, AND ONLY SEND ONE REPORT. THE PART NUMBERS THAT WERE RETURNED ARE 02.210.120 AND 02.210.118. SYNTHES CANNOT IDENTIFY WHICH OF THE RETURNED DEVICES IS THE COMPLAINED DEVICE. THIS REPORT IS FOR 3 UNKNOWN LOTS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT ORIF OF THE LEFT DISTAL RADIUS ON (B)(6) 2012. ON (B)(6) 2013, PATIENT RETURNED TO THE CLINIC COMPLAINING OF PAIN. X-RAYS REVEALED THAT THE MOST DISTAL AND RADIAL LOCKING SCREW HAD BACKED OUT OF THE PLATE. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED TO TWO .45 K-WIRES THROUGH THE RADIAL STYLOID INTO THE ULNAR SIDE OF THE DISTAL RADIUS. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124997 2.4MM VA LOCKING SCREW STARDRIVE 20MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention