BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CORTEX SCREW 30MM

    MDR report key: 7003276 · Received November 6, 2017

    Report

    Report Number
    3000270450-2017-10383
    Event Type
    Injury
    Date Received
    November 6, 2017
    Report Date
    October 12, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K131186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (CORTSCR Ø3.5 L30 TI, PART NUMBER 404.030S, LOT NUMBER 9232207). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING: ALL THE RELEVANT FEATURES WERE MEASURED ACCORDING TO THE DRAWING AND HAVE PASSED THEIR SPECIFICATIONS. BESIDES, DURING THE MANUFACTURING PROCESS, THESE RELEVANT FEATURES WERE INSPECTED AND DOCUMENTED ACCORDING TO THE INSPECTION SHEET, NO DEVIATIONS WERE DETECTED. THE RESULTS SHOW THAT THE SCREW WAS MANUFACTURED WITHIN THE SPECIFICATIONS. THE CHECK OF THE MATERIAL CERTIFICATE SHOWS THAT THE USED MATERIAL FULFILLS THE SPECIFICATIONS. THIS COMPLAINT IS RATED AS CONFIRMED SINCE THE SCREW IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW THIS COMPLAINT IS RATED AS NOT VALID BECAUSE THE RELEVANT DIMENSIONS WERE MEASURED AND ALL HAVE PASSED THE SPECIFICATIONS. NO MANUFACTURING ISSUE COULD BE FOUND IN THE RESULTS NEITHER IN THE MANUFACTURING DOCUMENTATION REVIEWED. THE MOST PROBABLE ROOT CAUSE FOR THE LCP PLATE 426.641S BREAKAGE WAS CAUSED BY PSEUDO ARTHROSIS AS REPORTED TOGETHER WITH THE BROKEN SCREWS. 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

    DATE OF EVENT: DATE OF POSTOPERATIVE SCREW BREAKAGE IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: KWQ, HRS. (B)(4). DATE OF ORIGINAL IMPLANT REPORTED AS (B)(6) 2015; HOWEVER, THE EXACT DATE IS UNKNOWN. CONCOMITANT MEDICAL PRODUCT: THERAPY DATE IS (B)(6) 2015; HOWEVER, THE EXACT DATE IS UNKNOWN. X-RAY REVIEW WAS PERFORMED. THE LATERAL BROAD LCP IS BROKEN IN THE SECOND FILM WITH NO SCREWS BROKEN. THE NARROW ANTERIOR LCP HAS ONE BROKEN SCREW, THE SCREW DISTAL AND JUST ADJACENT TO THE NONUNION. THERE MAY BE A FEW MORE BUT THE AP VIEW ONLY MAKES IT DIFFICULT TO DETERMINE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 404.030S, LOT # 9232207: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY. MANUFACTURING LOCATION: (B)(6), SUPPLIER: (B)(6), MANUFACTURING DATE: 05.NOV.2014, EXPIRY DATE: 01.OCT.2024: 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. NON-STERILE 404.030 / 9159972: MANUFACTURING LOCATION: (B)(6), MANUFACTURING DATE:15.SEP.2014: NO 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICES WERE USED IN THE SURGERY FOR THE FEMORAL DIAPHYSIS FRACTURE IN (B)(6) 2015, AN EXACT DATE IS UNKNOWN. THE BROAD LCP PLATE (14 HOLES) AND THE SMALL LCP PLATE (10 HOLES) WERE USED FOR THE BONE FIXATION. HOWEVER, PSEUDOARTHROSIS OCCURRED, AND THEN THE BROAD LCP PLATE WAS BROKEN AT THE TWO FINGERBREADTHS DISTAL TO THE PSEUDOARTHROSIS POINT IN (B)(6) 2017. ALTHOUGH THE MEDICAL OBSERVATION WAS TAKEN ONCE, THE FIVE SCREWS FOR THE SMALL LCP PLATE WERE BROKEN GRADUALLY THEREAFTER. AS A RESULT, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. NO DELAY IN THE REVISION SURGERY WAS REPORTED. PATIENT OUTCOME IS REPORTED AS OKAY. CONCOMITANT DEVICES REPORTED: 3.5MM TI LOCKING SCREW 14MM (PART # 412.103S, LOT # 8353494, QUANTITY 1); 3.5MM TI LOCKING SCREW 32MM (PART # 412.112S, LOT # 8418269, QUANTITY 1); 5.0MM TI LOCKING HEAD SCREW 40MM (PART # 413.340S, LOT # 9032956, QUANTITY 1); 5.0MM TI LOCKING HEAD SCREW 42MM (PART # 413.342S, LOT # 9576225, QUANTITY 1); LOCKING SCREW Ø5 SELF-TAP L12 TAN (PART # 04.221.462S, LOT # 9061626, QUANTITY 1); 5.0MM TI LOCKING SCREW SELF-TAPPING 14MM (PART # 422.402S, LOT # 9225667, QUANTITY 2); 5.0MM TI LOCKING SCREW SELF-TAPPING 14MM (PART # 422.402S, LOT # 9221607, QUANTITY 1); 4.5MM TI THREADED CERCLAGE POSITIONING PIN (PART # 498.803.01S, LOT # 9801620, QUANTITY 1); 4.5MM TI THREADED CERCLAGE POSITIONING PIN (PART # 498.803.01S, LOT # 7964768, QUANTITY 1); 3.5MM TI CORTEX SCREW 32MM (PART # 404.032, LOT # 9089945, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM TI CORTEX SCREW 30MM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782922 3.5MM TI CORTEX SCREW 30MM SCREW,FIXATION,BONE HWC SYNTHES SELZACH 9232207

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention