BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4674475 · Received April 9, 2015

    Report

    Report Number
    2520274-2015-12636
    Event Type
    Injury
    Date Received
    April 9, 2015
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHE USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED ¿ THREE (3) INTACT 6.5MM CANCELLOUS BONE SCREWS MADE OF STAINLESS STEEL, AND SEVEN (7) INTACT 4.5 MM CORTEX SCREWS MADE OF STAINLESS STEEL WERE RECEIVED. OF THE TEN SCREWS THAT WERE RETURNED, IT IS NOT DECIPHERABLE WHICH ONE (1) SCREW WAS LOCATED AT THE SIXTH PROXIMAL PLATE HOLE CLOSE TO THE AREA OF BONE FRACTURE. 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

    ADDITIONAL NARRATIVE: THE FOLLOWING PART AND LOT NUMBERS WERE PROVIDED BUT IT IS UNKNOWN WHICH WAS THE SCREW INVOLVED IN THE COMPLAINED EVENT: PART 214.026 4.5MM CORTEX SCREW 26MM, LOT 8348292, QUANTITY 1, MANUFACTURING LOCATION: (B)(4), 510K: K112583, MANUFACTURING DATE: MARCH 13, 2013. PART 214.042 4.5MM CORTEX SCREW 42MM, LOT 8483304, QUANTITY 2, MANUFACTURING LOCATION: (B)(4), 510K: K112583, MANUFACTURING DATE: JUNE 13, 2013. PART 214.044 4.5MM CORTEX SCREW 44MM, LOT 8474071 QUANTITY 1, MANUFACTURING LOCATION: (B)(4), 510K: K112583, MANUFACTURING DATE: JUNE 11, 2013. PART 214.046 4.5MM CORTEX SCREW 46MM, LOT 8446208, QUANTITY 1, MANUFACTURING LOCATION: (B)(4), 510K: K112583, MANUFACTURING DATE: MAY 21, 2013. PART 214.040 4.5MM CORTEX SCREW 40MM, LOT 8592096, QUANTITY 1, MANUFACTURING LOCATION: (B)(4), 510K: K112583, MANUFACTURING DATE: AUGUST 26, 2013. PART 214.050 4.5MM CORTEX SCREW 50MM, LOT 2017430, QUANTITY 1, MANUFACTURING LOCATION: (B)(4), 510K: K112583, MANUFACTURING DATE: OCTOBER 19, 2001. PART 218.060 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/60MM, LOT 8654239, QUANTITY 1, MANUFACTURING LOCATION: (B)(4), 510K: K061621, MANUFACTURING DATE: OCTOBER 04, 2013. PART 218.070 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/70MM, LOT 8052538, QUANTITY 2, MANUFACTURING LOCATION: (B)(4), 510K: K061621, MANUFACTURING DATE: AUGUST 30, 2012 . (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL POTENTIALLY INVOLVED PART/LOTS 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A BREAKAGE OF IMPLANT POSTOP OF A 4.5 CORTICAL SCREWS AND 6.5 CANCELLOUS BONE SCREW, IT WAS CLOSE TO THE SCREW HOLE, LOT NO.- NOT KNOWN, (B)(6) 2015, COMPLAINT SAMPLE AVAILABLE FOR EVALUATION, PATIENT IS STABLE NOW, REVISION SURGERY DONE (IMPLANT USED LCP DISTAL FEMUR PLATE) ONE OF THE SCREW BROKE AND EVENT DATE IS NOT CONFIRMED/UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE WAS BROKEN AT A SCREW HOLE. ALL SCREWS WERE INTACT. THIS WAS DISCOVERED POST-OPERATIVELY. THE DEVICE WAS INITIALLY IMPLANTED ON (B)(6) 2014 AND WAS EXPLANTED ON (B)(6) 2015. THE PATIENT¿S CONDITION IS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236861 SCREW, FIXATION, BONE HWC SYNTHE USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention