BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX REDUCTION SCREW 50MM THREAD LENGTH

    MDR report key: 5060516 · Received September 8, 2015

    Report

    Report Number
    3000270450-2015-10176
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 11, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DHR REVIEW FOR NON STERILE ARTICLE: 04.634.750 LOT 6860561 WAS MANUFACTURED IN (B)(4). DHR REVIEW 08-31-15, (B)(4). MANUFACTURE DATE: 01-18-12. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE 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

    AS THE DEVICE WAS RETURNED, IT CAN BE CONCLUDED THAT THE DEVICE WAS NOT IMPLANTED A MANUFACTURING EVALUATION WAS PREFORMED: PRODUCT RECEIVED WITH SCREW/BODY ASSEMBLED WITH DAMAGED PEEL FROM BROKEN SCREW DRIVER (03.616.042) STUCK IN THE M6.5 X 0.75-6H THREAD OF SCREW, WHICH IS NOT RELATED TO THE MANUFACTURING PROCESS. THE PERIPHERY OF THE BODY HAS NICKS AND SCRATCHES, ALSO VISIBLE ARE THE MOON SHAPED MARKS WHERE EXTENSION TABS WERE REMOVED. COMPLAINT CATEGORY STATES PRODUCT BROKEN, BUT IT IS IN FACT THE SCREW DRIVER THAT IS BROKEN AND COMPLAINT SHOULD STATE THE SCREW DRIVER THAT IS BROKEN AND COMPLAINT SHOULD STATE THE SCREW DRIVER BROKE AND LEFT A PEEL IN THE SCREWS THREAD. THE SCREWS INTERNAL THREAD AND MINOR DIAMETER COULD NOT BE MEASURED BECAUSE OF BEING ASSEMBLED AND PEELED THREAD FROM SCREW DRIVER IS OBSCURING ACCESS TO IDENTIFIED FEATURES. DUE TO THE REMOVAL OF THE PEEL WOULD DAMAGE THE M6.5 X 0.75-6H THREAD; NO DIS-ASSEMBLY WILL BE REQUESTED. THERE IS NO COMPLAINT AGAINST THE SCREW. 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 NOT PROVIDED BY REPORTER. IMPLANT DATE: UNKNOWN IF BROKEN DEVICE WAS IMPLANTED . EXPLANT DATE: DEVICE NOT REPORTEDLY EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW ¿ STERILE ARTICLE INFORMATION, NO DEVIATION WAS FOUND. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE:12 MARCH 2012. EXPIRY DATE:1 FEBRUARY 2022. 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: THE MATRIX SPINAL SYSTEM WAS APPLIED FOR SPINAL CANAL STENOSIS AT REGION FROM L5 TO SACRUM. DURING THE PROCEDURE, THE SURGEON FOUND THE REPORTED RETAINING SLEEVE WAS BROKEN. SURGEON ATTEMPTED TO INSERT THE REDUCTION SCREW IN THE PATIENT'S LEFT S1 HOWEVER IT WAS CUT OFF. THE SURGEON REMOVED THE SCREW AND TRIED TO ENGAGE IT WITH THE DRIVER, HOWEVER THE ATTEMPT WAS UNSUCCESSFUL. WHEN THE SURGEON CHECKED THE SCREW AND SLEEVE, IT WAS FOUND THAT THE TIP OF THE RETAINING SLEEVE WAS BROKEN AND ITS FRAGMENT REMAINED WITH THE SCREW. THE REDUCTION SCREW ALSO BROKE INTRA-OPERATIVELY. NO SURGICAL DELAY WAS REPORTED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593707 7.0MM TI MATRIX REDUCTION SCREW 50MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES SELZACH 7808967

    Patients

    Seq Age Sex Outcome Treatment
    1