BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø1.5 SELF-TAP L10 TAN

    MDR report key: 7108822 · Received December 12, 2017

    Report

    Report Number
    8030965-2017-50540
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE PART NUMBER: 04.130.210S . SYNTHES LOT NUMBER: 9896585. RELEASE TO WAREHOUSE DATE: 08.APR.2016 EXPIRY DATE: 01.APR.2026 . MANUFACTURING SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. 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. PART NUMBER: 04.130.210S, SYNTHES LOT NUMBER: 9865063, RELEASE TO WAREHOUSE DATE: 23.APR.2016 EXPIRY DATE: 01.MAR.2026, MANUFACTURING SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. 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. A MANUFACTURING INVESTIGATION WAS PERFORMED WAS PERFORMED FOR THE SUBJECT DEVICE: 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 10MM 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. WE LIKE TO REFER ON TO THE SURGICAL GUIDE WAS REVIEWED AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    510K: THIS REPORT IS FOR TWO UNKNOWN PROXIMAL SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. PATIENT CODE (B)(4) USED TO CAPTURE THE ADDITIONAL MEDICAL INTERVENTION NEEDED TO REMOVE THE PLATE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    CORRECTED DATA: CONCOMITANT DEVICES; THIS COMPLAINED DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. 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 (B)(4) 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 ANTHER 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 (1.5MM). 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); 1.5MM T-SHAPE PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR TWO UNKNOWN PROXIMAL SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    CORRECTION TO CONCOMITANT DEVICES: ONE OF THE CONCOMITANT CORTEX SCREWS HAS A LENGTH OF 14MM INSTEAD OF 12MM AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889627 VA LOCKSCR Ø1.5 SELF-TAP L10 TAN SCREW, FIXATION, BONE HWC OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention