BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX REDUCTION SCREW 40MM THREAD LENGTH

    MDR report key: 3831648 · Received May 26, 2014

    Report

    Report Number
    2530088-2014-10138
    Event Type
    Injury
    Date Received
    May 26, 2014
    Report Date
    April 21, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMMON DEVICE NAMES: MNH, MNI, KWQ, KWP. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NO NON-CONFORMANCE REPORTS 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. 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 EVALUATION WAS COMPLETED: OUR INVESTIGATION SHOWS THAT THE SCREW IS WORN OUT AT THE SCREW RECESS AND THE CHUCK OF THE UNIVERSAL HEAD IS BENT. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE RECEIVED INFORMATION WE CANNOT DETERMINE THE EXACT ROOT CAUSE. IT IS LIKELY THAT A MECHANICAL OVERLOAD SITUATION WHILE IN USE (WITH A POSSIBLE DAMAGED SCREWDRIVER) HAS LED TO THESE DAMAGES. UNFORTUNATELY THE SCREWDRIVER ITSELF WAS NOT RETURNED FOR INVESTIGATION. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE UNIVERSAL HEAD OF THE REDUCTION SCREW BROKE AWAY FROM THE SCREW UNDER COMPRESSION DURING THE SURGERY. IT WAS FURTHER REPORTED THIS EVENT RESULTED IN PROLONGATION OF THE HOSPITAL STAY, NO FURTHER INFORMATION WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309957 6.0MM TI MATRIX REDUCTION SCREW 40MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7494493

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention