BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI 12-POINT NUT-11MM

    MDR report key: 6140136 · Received December 1, 2016

    Report

    Report Number
    3000270450-2016-10282
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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

    (B)(4). LOT NUMBER IS EITHER L00514 OR L091382, BUT IT IS UNKNOWN WHICH IS THE COMPLAINED LOT. L00514 IS NOT A VALID LOT NUMBER, BUT MOST LIKE CORRECT POTENTIAL LOT NUMBER IS L100514. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR BOTH POTENTIAL LOT NUMBERS WAS COMPLETED: MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). MANUFACTURING DATE: L100514 ¿ AUGUST 23, 2016; L091382 ¿ AUGUST 10, 2016. EXPIRY DATE: BOTH - AUGUST 01, 2026. THE DEVICES WERE INITIALLY MANUFACTURED IN (B)(4) UNDER THE UNSTERILE LOTS L086759 AND L074488 RESPECTIVELY AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE DOCUMENTS OF THE UNSTERILE LOTS FROM (B)(4) WERE REVIEWED. THIS REVIEW HAS SHOWN THAT NO NON-CONFORMANCE REPORTS 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE SURGERY WAS A PAEDIATRIC DEFORMITY CASE. BOTH NUTS THREADS STRIPPED DURING THE SAME SURGERY.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(4) AS FOLLOWS: IT WAS REPORTED THAT WHEN TIGHTENING THE NUT ONTO THE SLEEVE THE NUT STRIPPED. THIS HAPPENED TWICE WITH TWO DIFFERENT NUTS DURING THE SAME CASE. THE CASE WAS COMPLETED SUCCESSFULLY. THE BROKEN OFF PART WAS REMOVED AND REPLACED WITH A NEW IMPLANT. THERE WAS NO PATIENT IMPACT AND THE SURGERY WAS NOT PROLONGED. CONCOMITANT REPORTED PART: SLEEVE (PART AND LOT NUMBER UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788265 TI 12-POINT NUT-11MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN SLEEVE