BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM

    MDR report key: 7264340 · Received February 12, 2018

    Report

    Report Number
    8030965-2018-51044
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    10886982112750
    PMA / PMN Number
    K141527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PRODUCT CODE: HRS. AS FOUR (4) SCREWS WITH LENGTH OF 10 MM ARE REPORTED WITH TWO DIFFERENT LOT NUMBERS (9896585 AND 9865063) WE DON¿T KNOW WHICH LOT NUMBER MATCHES THE TWO SCREWS STILL REMAINING IN PLATE. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(4). PART 04.130.210S, LOT 9896585: RELEASE TO WAREHOUSE DATE: APRIL 08, 2016. EXPIRY DATE: APRIL 01, 2026. PART 04.130.210S, LOT 9865063: RELEASE TO WAREHOUSE DATE: APRIL 23, 2016. EXPIRY DATE: MARCH 01, 2026. MANUFACTURING SITE: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: BASED ON THE RECEIVED CONDITION OF THE TWO SCREWS, THEY ARE CONNECTED TOGETHER WITH THE PLATE AND WILL NOT GET DETACHED WE CAN CONFIRM THAT THERE MUST BE A PROBLEM WITH LOCKING IN TO THE PLATE. AS FOUR (4) SCREWS WITH LENGTH OF 10 MM ARE REPORTED WITH TWO DIFFERENT LOT NUMBERS WE DON¿T KNOW WHICH LOT NUMBER DOES MATCH TO THE TWO SCREWS STILL REMAINING IN PLATE. REVIEW OF THE DHR TO LOT NUMBER 9896585 AND 9865063 DID NOT SHOW ANY DEVIATION TO SPECIFICATIONS. FURTHER INVESTIGATIONS (INCLUDING DIMENSIONAL INSPECTION) WERE NOT POSSIBLE AS BOTH SCREW HEADS ARE STILL STICKING IN PLATE AND IT IS UNKNOWN WHICH LOT IS AFFECTED. BASED ON THE DHR REVIEW WE COULD NOT FIND ANY MANUFACTURING RELATED DEVIATIONS. THE MATERIAL WAS DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. THE EXACT ROOT CAUSE FOR THIS COMPLAINED PROBLEM COULD NOT BE REPLICATED. A FUNCTIONAL TEST TO REPLICATED THE COMPLAINT CONDITION COULD NOT BE PERFORMED. THE RELEVANT DRAWING WAS REVIEWED AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS USED IN THE SURGERY FOR THE FRACTURE OF THE LEFT SECOND METACARPAL BONE ON (B)(6) 2017. THE VARIABLE ANGLE (VA) LOCKING Y-SHAPE PLATE WAS USED FOR THE FIXATION. AFTER THE FIXATION WITH THE PROXIMAL THREE SCREWS AND DISTAL TWO SCREWS BY USING THE VA SLEEVE, RE-REDUCTION WAS NEEDED SO THE DISTAL SCREWS WERE REMOVED ONCE. WHEN THE VA DRILLING WAS DONE AGAIN AFTER RE-REDUCTION, THE LOCKING SCREW WAS INSERTED AND IT WAS FOUND THAT THE PLATE WAS NOT LOCKED BY THE SCREW. WHEN THE FIX-MODE DRILLING WAS DONE TO ANOTHER HOLE, AND THE LOCKING SCREW WAS INSERTED, IT WAS ALSO FOUND THAT THE PLATE WAS NOT LOCKED BY THE SCREW. BECAUSE THE FIXATION WAS NOT POSSIBLE AT THIS MOMENT, THE SURGEON DECIDED TO REPLACE THE PLATE IN QUESTION. WHEN THE SURGEON TRIED TO REMOVE THE Y-SHAPE PLATE IN QUESTION, THE PLATE COULD NOT BE REMOVED SINCE THE PROXIMAL TWO SCREWS WERE SPINNING AROUND. EVENTUALLY, THE PLATE IN QUESTION WAS CUT AND REMOVED FROM THE PATIENT. THE SURGEON REPLACED AND FIXED WITH THE T-SHAPE PLATE (1.5 MM). THE SURGEON COMMENTED THAT SINCE THE VA SLEEVE WAS DRILLED BEYOND THE RANGE OF THE SPECIFIED VALUE, THE PLATE IN QUESTION MIGHT HAVE NOT BEEN LOCKED WITH THE LOCKING SCREW; OR THE FORCE OF LOCKING TIGHTENING MIGHT HAVE BEEN TOO STRONG. THE SURGERY WAS EXTENDED FOR AN UNKNOWN DURATION. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICES: CORTEX SCREW (PART 04.214.112S, LOT 9864479, QUANTITY 1); CORTEX SCREW (PART 04.214.112S, LOT 9850336, QUANTITY 1); VA LOCKING SCREW (PART 04.130.210S, LOT 9896585, QUANTITY 2); VA LOCKING SCREW (PART 04.130.210S, LOT 9865063, QUANTITY 2); VA LOCKING SCREW (PART 04.130.212S, LOT 9888781 OR 9882709, QUANTITY 1); VA SLEEVE (PART/LOT UNKNOWN, QUANTITY 1); 1.5 MM T-SHAPE PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107942 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 04.130.210 10886982112750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention