BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE

    MDR report key: 6428237 · Received March 23, 2017

    Report

    Report Number
    3000270450-2017-10100
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 1, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). (B)(6). THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: OCT 7, 2016. EXPIRATION DATE: SEP 1, 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. (B)(4) WAS UTILIZED FOR REVISION SURGERY. 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

    FOR THE NON-STERILE DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 20-SEP-2016. PART NO: 04.210.118, LOT NO: H189654 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM. QUANTITY (B)(4). COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.018.999 2.8MM TI SCREW BLANK 18MM. BP55, LOT H182760 MEET SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING EVALUATION HAS BEEN COMPLETED. FIVE SCREWS WERE RETURNED FOR EVALUATION. PER THE COMPLAINT THE FIVE SCREWS HAVE BEEN IDENTIFIED AS: P/N 04.210.118, US LOT NUMBER H189654, EU LOT NUMBER L158610, QTY 1; P/N 04.210.118, US LOT NUMBER H201751, EU LOT NUMBER L226583, QTY 2; P/N 04.210.120, US LOT NUMBER H197435, EU LOT NUMBER L170281, QTY 1; P/N 04.210.122, US LOT NUMBER 9953272, EU LOT NUMBER 9765202, QTY 1. ALL FIVE SCREWS WERE RECEIVED BROKEN AT THE NECK AREA OF THE SCREW. FOR 3 OUT OF 5 SCREWS BOTH THE HEAD AND SHAFT PIECES WERE AVAILABLE FOR EVALUATION. FOR 2 OUT OF 5 SCREWS, ONLY THE SHAFT PIECE WAS RETURNED FOR EVALUATION. SINCE THE OVERALL LENGTH CANNOT BE MEASURED DUE TO THE MISSING PIECES OR BREAKAGE, IT CANNOT BE DETERMINED WHICH SCREW PART NUMBER BELONGS TO WHICH PART. THEREFORE SCREWS WILL BE IDENTIFIED BY SCREW NUMBERS 1 THROUGH 5. ALL FIVE SCREWS HAD DAMAGE AT THREADS NEAR THE BREAK SITE. DEBRIS IS VISIBLE NEAR THE FLUTES ON SCREWS 1 AND 2. SCREW 3 HAS DAMAGE NEAR THE FLUTE END AND DEBRIS IS VISIBLE IN THE DAMAGED AREA. SCREW 4 HAS THREAD DAMAGED LOCATED 2 TO 3 THREADS BELOW BREAK SITE AND DEBRIS IS VISIBLE IN DAMAGED THREAD SECTION. SCREW 5 HAS THREAD DAMAGE ALONG THE ENTIRE SHAFT LENGTH. THE THREAD PROFILE, THREAD MINOR DIAMETER AND THREAD MAJOR WERE CHECKED ON ALL FIVE SCREWS AT THREAD SECTIONS. NO DAMAGE OR OTHER ISSUES WERE FOUND. THE MATERIAL TYPE WAS CONFIRMED FOR ALL FIVE SCREWS. ALL FIVE SCREWS BROKE BELOW THE SCREW HEAD. THE HEAD/NECK PROFILE COULD NOT BE EVALUATED DUE TO THE UNAVAILABILITY OF THE ENTIRE HEAD OR DAMAGE DUE TO BREAK. THE AVAILABLE DATA SUPPORTS THE COMPLAINANT¿S DESCRIPTION "FIVE SCREWS WERE BROKEN". THEREFORE, THIS COMPLAINT IS CONFIRMED. HOWEVER, SINCE ALL THE RELEVANT FEATURES COULD NOT BE EVALUATED IT IS UNKNOWN IF THE CAUSE OF THE COMPLAINT CONDITION IS A RESULT OF THE MANUFACTURING PROCESS. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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 (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WITH HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 DUE RE-FRACTURE OF THE DISTAL RADIUS AND FIVE (5) BROKEN SCREWS. THE PATIENT HAD INITIALLY UNDERGONE SURGERY WITH PLATE AND SCREW IMPLANTATION TO TREAT THE DISTAL RADIUS FRACTURE ON (B)(6) 2017. THE PATIENT RE-FRACTURED THE SITE ON AN UNKNOWN DATE. THE SURGEON COMMENTED THAT THE PATIENT HAD NOT FALLEN DOWN. DURING THE REVISION SURGERY ON (B)(6) 2017, ALL OF THE IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED WITH A COMPETITOR¿S PLATE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTEDLY GOOD. CONCOMITANT DEVICES: 1X 04.111.630S / 9851629 (VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO). THIS REPORT IS 1 OF 5 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210036 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE PLATE, FIXATION, BONE HRS SYNTHES SELZACH L158610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.111.630S, 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL