BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM

    MDR report key: 6773764 · Received August 8, 2017

    Report

    Report Number
    9612488-2017-10388
    Event Type
    Injury
    Date Received
    August 8, 2017
    Report Date
    July 12, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    UDI-DI
    07611819240667
    PMA / PMN Number
    K023941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 413.375, LOT # 9457058: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 27. APRIL 2015: NO NON CONFORMANCE REPORTS (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. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    CUSTOMER QUALITY COMPLETED AN INVESTIGATION OF THE RETURNED DEVICE. DIMENSION THE RELEVANT MEASURABLE DIMENSIONS OF THE LOCKING SCREW (413.375 / 9457058) CANNOT BE DETERMINED, BECAUSE THE SHAFT IS MISSING AND THE SCREW HEAD STUCK IN THE LCP-DF PLATE. THE HEXAGON RECESS OF THE LOCKING SCREW IS STRONGLY DAMAGED. MATERIAL THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-11 FOR TAN (WROUGHT TITANIUM 6-ALUMINIUM 7-NIOBIUM ALLOY). THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. CONCLUSION NO PRODUCT FAULT COULD BE DETECTED. THE LOCKING SCREW WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) PIECES IN APRIL 2015. THE EVALUATION OF THE LOCKING SCREW SHOWS THAT THE SCREW HEAD STUCK IN THE LCP-DF-PLATE. THE SHAFT IS MISSING AND FOR FURTHER INVESTIGATION NOT AVAILABLE. ACCORDING STATEMENT OF CLINIC, THE SCREWS WERE DISCARDED BY THE HOSPITAL. FURTHER INVESTIGATION OF THE SCREW HEAD SHOWN THAT THE HEXAGON RECESS ARE STRONGLY DAMAGED. PART 413.375, BROKEN POSTOPERATIVELY, FAMILY: 5.0 TI LOCKING SCREWS, SELF TAPPING FAMILY (413.314-.390). THE COMPLAINT IS ADEQUATELY ADDRESSED BY THE RISK ASSESSMENT. UNK - SCREW THERE IS NOT ENOUGH INFORMATION PROVIDED TO ADEQUATELY IDENTIFY THE PART NUMBER OR PART FAMILY FOR THE COMPLAINT PART(S). AS SUCH, A DCRM REVIEW CANNOT BE PERFORMED AT THIS TIME. COMPLAINT IS DISPOSED AS CONFIRMED DUE TO EVIDENCE THAT THE SCREW IS BROKEN, BUT IT'S CONSIDERED NOT VALID FOR MANUFACTURING STANDPOINT BECAUSE THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. THE REASON FOR THE BREAKAGE AND DEFORMATION WE CANNOT DETERMINED. WE CAN ONLY ASSUME THAT THIS CAN BE TRACED DURING INSERTION OR REMOVAL OR THERE WAS A COMPLICATION DURING OPERATION OR THE HEALING PROCESS THAT CAUSED THIS PROBLEM. 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 THAT A PATIENT WAS INITIALLY IMPLANTED WITH LOCKING COMPRESSION PLATE (LCP) AND UNKNOWN NUMBER OF SCREWS ON (B)(6) 2015. POSTOPERATIVELY ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE MULTIPLE CANCELLOUS SCREW HEADS ARE BROKEN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. NO INFORMATION ABOUT PATIENT STATUS. CONCOMITANT DEVICE REPORTED: TI LCP(TM) DISTAL FEMUR PLATE 7 HOLES/196 MM-RIGHT (PART # 422.252, LOT # 8192220, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0 MM TI LOCKING HEAD SCREW SELF-TAPPING 75 MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553958 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM APPLIANCE,FIXATION,NAIL KTT SYNTHES BETTLACH 9457058 07611819240667

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention PLATE (PART # 422.252, LOT # 8192220, QUANTITY 1)