BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 10MM-STERILE

    MDR report key: 6356110 · Received February 24, 2017

    Report

    Report Number
    3000270450-2017-10057
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 30, 2017
    Report Date
    January 30, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: OCT 9, 2012. EXPIRATION DATE: OCT 1, 2022. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR NON-STERILE PART# 04.210.110, LOT# 7000902. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUG 04, 2012. DHR REVIEW WAS COMPLETED FROM THE RAW MATERIAL TO THE FINISHED NON-STERILE SCREW. RAW MATERIAL PART# 23030, LOT# 6589820, BLANK COMPONENT PART# 04.210.106.999, LOT# 6900923, PART# 04.211.010.999, LOT# 6915440, PART# 04.210.110, LOT# 7000902. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. MICROSCOPIC INVESTIGATION SHOWS THAT THE LOCKING THREAD IS PLASTICALLY DEFORMED. AS RESULT OF THIS DEFORMATION, THE SCREW FINALLY PENETRATED THE PLATE AS COMPLAINED. THIS DEFORMATION IS CLEARLY FROM POST MANUFACTURING HANDLING INDICATING EXCEEDING APPLIED TORSIONAL FORCE WHILE INSERTION. ALSO THE VISIBLE SIGNS AT THE SCREW HEAD INDICATE THIS PHENOMENON. THE TORX RECESS IS ALSO DEFORMED AND SHOWS SIGNS OF HARD MECHANICAL LOADING WITH THE SCREWDRIVER. DUE TO THESE DAMAGES, IT IS NOT POSSIBLE TO MEASURE THE RELEVANT DIMENSIONS. HOWEVER, AS RESULT OF THESE FINDINGS WE CAN EXCLUDE MANUFACTURING RELATED ISSUE. NO PRODUCT RELATED ISSUE COULD BE IDENTIFIED. WE ARE NOT ABLE TO IDENTIFY THE ROOT CAUSE FOR THE REPORTED PROBLEM. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR TO TREAT A DISTAL RADIUS FRACTURE ON (B)(6) 2017, THE VARIABLE ANGLE (VA) LOCKING SCREW PENETRATED THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) AND MOREOVER THE SCREW PROTRUDED FROM DORSAL SIDE. THE SURGEON THEN EXTRACTED THE SCREW. THE VA-LCP PLATE WAS USED BUT THE SURGEON DIDN¿T INSERT ANYTHING IN THE REPORTED PLATE HOLE OF CONCERN AND COMPLETED THE SURGERY. THE PATIENT WAS WELL SO FAR, PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL PROLONGATION OF UNKNOWN DURATION DUE TO THE REPORTED EVENT. CONCOMITANT DEVICES: 1X 04.111.541S / 3755097 (VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA). THIS REPORT IS 1 OF 1 FOR (B)(4). (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138761 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH 8100662

    Patients

    Seq Age Sex Outcome Treatment
    1 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H LT-STER