BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LOCKING SCREW SELF-TAPPING 36MM

    MDR report key: 5448580 · Received February 19, 2016

    Report

    Report Number
    2520274-2016-11169
    Event Type
    Injury
    Date Received
    February 19, 2016
    Report Date
    February 2, 2016
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION SUMMARY ¿ THE PRODUCT WAS NOT RETURNED IN THE ORIGINAL PACKAGING. THE LASER ETCHING WAS READABLE. THE SCREWS SHOWS USAGE MARKS. ALL MEASURABLE DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE MATERIAL CERTIFICATE OF THE RAW MATERIAL LOT USED WAS REVIEWED AND SHOWS ALL SPECIFICATIONS WERE FULFILLED. THE COMPLAINT CONDITION IS CONFIRMED; HOWEVER IT IS NOT VALID FROM A MANUFACTURING STANDPOINT. DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MARCH 10, 2014. 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 LOT NUMBER OF: 8890022 WAS PROVIDED. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW - DHR-REVIEW WAS NOT POSSIBLE AS LOT NUMBER DOES NOT MATCH TO ARTICLE NUMBER.¿ 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: A REVISION SURGERY TOOK PLACE ON (B)(6) 2016 DUE TO SCREWS THAT BACKED OUT AND NON-UNION. THE PATIENT WAS INITIALLY IMPLANTED WITH THE DEVICES ON (B)(6) 2014. IN (B)(6) 2014, DURING A ROUTINE CHECKUP, THE FORMATION OF CALLUS WAS CONFIRMED AND THE PATIENT WAS CLEARED FOR NORMAL ACTIVITIES. IN (B)(6) 2015 THE PATIENT COMPLAINED OF PAIN AND IT WAS FOUND THAT A SCREW HAD BACKED OUT AND NON-UNION WAS NOTED. ON (B)(6) 2016 REVISION SURGERY OCCURRED. DURING THE SURGERY, IT WAS CONFIRMED THE REPORTED TI LOCKING SCREWS HAD COMPLETELY BACKED FROM THE PLATE. THE SURGEON REMOVED ALL REPORTED IMPLANTS AND INSERTED A NAIL NON-SYNTHES NAIL. THE SURGEON ALSO MADE A FRESH FRACTURE PART AND GENERATED BONE GRAFT TO THE PATIENT. THIS IS REPORT 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103676 3.5MM TI LOCKING SCREW SELF-TAPPING 36MM APPLIANCE,FIXATION,NAIL KTT SYNTHES GRENCHEN 8890922

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention