BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 24MM

    MDR report key: 4737567 · Received April 29, 2015

    Report

    Report Number
    2520274-2015-13505
    Event Type
    Injury
    Date Received
    April 29, 2015
    Report Date
    April 13, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT ONE OF THESE LOTS BELONG TO THE UNKNOWN SCREW: 412.106 / 8891072: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 12. MAR. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 412.108 / 8838720: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 12. FEB. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 412.114 / 9133022: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 03. SEP. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 412.117 / 9202927: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 16. OCT. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 412.118 / 9300956: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 29. DEC. 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 412.117 / 9240943: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 11. NOV. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    WEIGHT IS AN APPROXIMATION. REPORTED AS (B)(6) 2015 BUT IT UNKNOWN WHEN EXACTLY THE DEVICE PULLED OUT. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT NUMBER. SEVERAL SCREWS WERE RECEIVED, IT IS UNKNOWN WHICH IS THE COMPLAINED SCREW. PART NUMBER: 412.106, LOT NUMBER: 8891072; PART NUMBER: 412.108, LOT NUMBER: 8838720; PART NUMBER: 412.114, LOT NUMBER: 9133022; PART NUMBER: 412.117, LOT NUMBER: 9202927; PART NUMBER: 412.118, LOT NUMBER: 9300956; PART NUMBER: 412.117, LOT NUMBER: 9240943. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    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

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT THE: TOTALLY 7 INTACT LOCKING SCREWS 412.1XX IN DIFFERENT LENGTHS WERE SEND BACK TOGETHER WITH THE BROKEN SCREWS AND THE PLATE. THE MANUFACTURING DOCUMENTS OF ALL THESE DEVICES WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE DETECTED. THE VISUAL INSPECTION OF THE LOCKING THREADS HAS SHOWN THAT ALL OF THEM ARE IN A VERY GOOD CONDITION, THE THREAD FLANKS OF THE LOCKING THREADS ARE INTACT AND SHOW ALMOST NO SIGNS OF USE. THE FUNCTION TEST HAS SHOWN THAT ALL RECEIVED SCREWS CAN BE LOCKED INTO THE INTACT PLATE HOLES AS REQUIRED. BASED ON THAT WE EXCLUDE THAT ANY ISSUE WITH ONE OF THESE LOCKING SCREWS DID CONTRIBUTE TO THE MENTIONED SCREW BACK OUT AND THEREFORE THE COMPLAINT IS UNCONFIRMED FOR THE RECEIVED INTACT SCREWS. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE PERFORMED INVESTIGATION OF THE BROKEN SCREWS DID NOT SHOW ANY MATERIAL OR MANUFACTURING RELATED FAULT, THE SCREWS WERE CONFORM WITH THE SPECIFICATION. IT WAS CONCLUDED THAT THE IMPLANT COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD I FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE ALSO PLAYED A CERTAIN ROLE. 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 SIX WEEKS AFTER THE INITIAL SURGERY WHILE THE PATIENT WAS DOING REHAB, SHE HEARD A CRACK AND FELT PAIN. WHEN THE X-RAY WERE TAKEN IT WAS POSSIBLE TO SEE TWO SCREWS BROKEN AROUND THE HEAD AND A THIRD SCREW PULLED OUT. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282327 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 24MM APPLIANCE, FIXATION, NAIL KTT SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention