BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 6804411 · Received August 18, 2017

    Report

    Report Number
    3000270450-2017-10295
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 25, 2017
    Report Date
    July 25, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1X ARTICLE 04.210.118S WITH LOT L150928 / VA LOCKSCR Ø2.4 SELF-TAP L18 TAN RECEIVED AND FORWARDED TO MANUFACTURING PLANT FOR INVESTIGATION: AS RECEIVED CONDITION OF DEVICE: THE STAR DRIVE OF THE RETURNED SCREW WAS VISUALLY EXAMINED AND THERE IS SIGNIFICANT DAMAGE AROUND THE INSIDE LOBES. THE STAR DRIVE DOES HAVE DEPTH; NOT DEPTHLESS AS PER COMPLAINT DESCRIPTION. INVESTIGATION SUMMARY: THE RETURNED SCREW WAS VISUALLY EXAMINED UNDER MAGNIFICATION. THE STAR DRIVE IS NOT "DEPTHLESS" AS DESCRIBED IN THE COMPLAINT DESCRIPTION. HOWEVER, THE STAR DRIVE TAPER AND STRAIGHT DEPTH COULD NOT BE MEASURED DUE TO THE DAMAGED DRIVE. THE DAMAGE/GALLING IS AROUND THE LOBES OF THE STAR DRIVE FEATURE WHERE DISPLACED MATERIAL CAN BE SEEN UNDER MAGNIFICATION WHICH INTERFERES WITH MEASUREMENT OF DRIVE. ALTHOUGH THE DRIVE DEPTH COULD NOT BE MEASURED THE DRIVE DOES HAVE DEPTH THEREFORE THE REVIEW OF THE SCREW DOES NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION. THIS COMPLAINT IS NOT CONFIRMED. DHR-REVIEW; NO FINDINGS. 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

    PATIENT INFORMATION IS UNKNOWN. UDI: (B)(4). IMPLANT DATE IS UNKNOWN. EXPLANT DATE IS UNKNOWN. TELEPHONE NUMBER IS UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 03.OCT.2016 EXPIRY DATE: 01.SEP.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 04.210.118 / H180409 WAS MANUFACTURED IN US. NON-STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 01-SEP-2016. PART NO: 04.210.118, LOT NO: H180409 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM. QUANTITY 240. COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.018.999, 2.8MM TI SCREW BLANK 18MM. BP55, LOT H178196 MEET SPECIFICATION. RAW MATERIAL WAS RELEASED TO BP55 ON 24-AUG-2016. INSPECTION SHEET FOR MILL SHAFT THREADS/HEAD THREAD/FLUTE FINAL INSPECTION MEETS INSPECTION ACCEPTANCE CRITERIA. 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. 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 THE DOCTOR AND CLINICAL NURSE COULDN'T FIX A COMPLAINT SCREW WITH DRIVER. AND THEN THE DOCTOR TRIED TO INSERT A COMPLAINT SCREW. IT'S POSSIBLE IT HAPPENED TO BREAK THIS SCREW HEAD HOLE. SO, HE STOPPED TO USE THIS SCREW, AND USED A NEW SCREW. HE COULD FINISH THE SURGERY WITH NO PROBLEM. THERE WAS NO SURGICAL DELAY REPORTED. HE ISSUES A SCREW HEAD HOLE IS DEPTHLESS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO REPORT ABOUT FRAGMENTS. CONCOMITANT DEVICE: 1X UNK SCREW DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585204 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN PLATE,FIXATION,BONE HRS SYNTHES SELZACH L150928

    Patients

    Seq Age Sex Outcome Treatment
    1