BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CORTEX SCREW 28MM

    MDR report key: 5804111 · Received July 19, 2016

    Report

    Report Number
    2520274-2016-13522
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 4, 2016
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    K131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRS. (B)(4). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 03, 2014. EXPIRY DATE: SEPTEMBER 01, 2024. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE 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

    ADDITIONAL NARRATIVE: NON-STERILE PART 404.028.999, LOT 785299: REVIEW LOCATION: (B)(4). MANUFACTURE DATES: SEPTEMBER 10, 2014. THE REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD (DHR) SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMANCES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: WE HAVE RECEIVED THE CORTEX SCREW BROKEN IN TO THREE PIECES. THE VISUAL INSPECTION HAS SHOWN THAT ONE PIECE STILL REMAINS IN THE RETURNED HOLLOW REAMER. THE SCREW IS BROKEN CLOSE TO THE SCREW HEAD AS COMPLAINED. THE THREADED SHAFT IS STRONGLY DAMAGED. THE HEXAGON ON THE HEAD OTHERWISE IS STILL IN GOOD CONDITION. THE STRONG DAMAGES AT THE THREAD WERE MOST PROBABLY CAUSED DURING REMOVAL WITH THE HOLLOW REAMER. THE FRACTURE SURFACE SHOWS THE TYPICAL VIEW OF A TORSION FRACTURE. THE CORE DIAMETER OF THE CORTEX SCREW WAS MEASURED AND FOUND TO BE CONFIRMING. THE MANUFACTURING DOCUMENT SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 9172214 WAS MANUFACTURED IN OCTOBER 2014. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. IT IS LIKELY THAT THE BREAKAGE OF THE SCREW MIGHT HAVE HAPPENED BY THE USE OF TOO MUCH SIDE FORCE BY INSERTION. ANOTHER REASON COULD BE THAT THE PLATE WAS TILTING WHILE INSERTING THE SCREW. A FAILURE IN MATERIAL OR MANUFACTURING COULD NOT BE DETECTED. BASED ON OUR INVESTIGATIONS A PRODUCT RELATED FAULT CAN BE EXCLUDED. NAME 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. THIS REPORT IS FOR ONE UNKNOWN 3.5MM CORTEX SCREW. PART AND LOT NUMBERS WERE NOT AVAILABLE FOR REPORTING OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, NO IMPLANT/EXPLANT DATES ARE APPLICABLE. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAVE NOT YET BEEN RECEIVED. (B)(6). WITHOUT A 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. 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

    IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    CONCOMITANT PART REPORTED: EXTRACTION BOLT (PART 309.039, LOT 224344, QUANTITY 1).

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING SURGERY TO TREAT A DISTAL TIBIA FRACTURE THE 3.5MM CORTEX SCREW BROKE DURING TIGHTENING. THE SURGEON TRIED TO INSERT THE REPORTED CORTEX SCREW INTO THE PLATE AS THE POSITIONING [SCREW]. THE SURGEON REPORTEDLY EXPERIENCED DIFFICULTY INSERTING THE CORTEX SCREW AFTER BEING TAPPED AT OPPOSITE SIDE OF THE PATIENT'S CORTICAL BONE ON THE SURGERY. THE DIFFICULTY WAS DUE TO STRONG RESISTANCE FOR INSERTING MORE THAN 5MM BEFORE THE HEAD OF THE CORTEX SCREW REACHED AT THE PLATE. WHEN THE SURGEON ATTACHED STARDRIVE SCREWDRIVER SHAFT TO HANDLE (WITH QUICK COUPLING) AND TRIED TIGHTENING THE REPORTED CORTEX SCREW UP, THE SCREW BROKE. THE FRAGMENT OF THE BROKEN SCREW WAS REMOVED FROM THE PATIENT USING A HOLLOW REAMER. THE SURGERY WAS EXTENDED FOR AN UNKNOWN DURATION OF TIME. THIS REPORT IS FOR ONE UNKNOWN 3.5MM CORTEX SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456791 3.5MM TI CORTEX SCREW 28MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 9172214

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR