BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 7005025 · Received November 6, 2017

    Report

    Report Number
    3000270450-2017-10382
    Event Type
    Injury
    Date Received
    November 6, 2017
    Report Date
    October 12, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALERT DATE IS UNKNOWN, UNKNOWN WHEN DEVICE ACTUALLY BROKE. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PATIENT CODE (B)(4) USED FOR: THE BONE SURROUNDING THE EMBEDDED SCREW WAS CHIPPED OFF AND THE REMAINED SCREW WAS REMOVED BY LUER FORCEPS. THE SCREW BROKE DURING REMOVAL FOR A PLANNED PROCEDURE. THERE WAS AN ADDITIONAL INTERVENTION TO REMOVE THE SCREW. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24-JUN-2016. PART NO: 04.210.120 (EU PART), LOT NO: H132435 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM. QUANTITY 239. COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.022.999 BP55, LOT H121438 MEET SPECIFICATION. 2.8MM TI SCREW BLANK 20MM 02.7 VARIABLE ANGLE W/SDB. BP 55. QUANTITY: 971. RELEASED TO BP55 ON 06-JUN-2016. INSPECTION SHEET FOR MILL THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION. 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. PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4) SUPPLIER: (B)(4) MANUFACTURING DATE: 20.JUL.2016 EXPIRY DATE: 01.JUL.2026 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. NON-STERILE (B)(4) WAS MANUFACTURED IN US. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED DEVICE WAS USED IN THE SURGERY FOR THE DISTAL RADIUS FRACTURE ON (B)(6) 2017. THE VA-TCP WAS USED FOR OSTEOSYNTHESIS. THE PLATE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2017 AND WAS A PLANNED SURGERY. DURING THE REMOVAL SURGERY, WHEN THE SURGEON TRIED TO REMOVE THE LOCKING SCREW, ONLY THE SCREW HEAD WAS REMOVED. THE SCREW WAS BROKEN AT THE ROOT OF THE SCREW HEAD. THE SCREW PART WAS LEFT IN THE BONE. AFTER THE PLATE WAS REMOVED, THE BONE SURROUNDING THE EMBEDDED SCREW WAS CHIPPED OFF AND THE REMAINED SCREW WAS REMOVED BY LUER FORCEPS. ACCORDING TO THE SURGEON¿S OPINION, THE SCREW HAD BEEN ALREADY BROKEN, NOT THAT THE SURGEON BROKE THE SCREW DURING THE PROCEDURE. THE SURGEON ALSO POINTED OUT THAT THE SUFFICIENT SCREW LOCKING MIGHT HAVE NOT BEEN DONE INITIALLY, WHICH LED TO THE METAL FATIGUE. THE REMOVAL SURGERY WAS EXTENDED FOR 20 MINUTES. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, PATIENT OUTCOME IS OK. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICES: 1X UNK PLATE, 1X UNK SCREW REMOVAL KIT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783897 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH L070221

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention