BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SLF TPING 14MM

    MDR report key: 2810043 · Received October 18, 2012

    Report

    Report Number
    2520274-2012-02310
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 19, 2012
    Manufacturer
    SYNTHES, INC.
    Product Code
    HRS
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION FROM MANUFACTURING EVALUATION AND INFORMATION IS NOT CONFIRMED. EIGHT SCREWS, SCREW PIECES WERE RECEIVED WITH THE TASKS ASSOCIATED WITH THIS COMPLAINT. EACH WILL BE BAGGED AND ARBITRARILY ASSIGNED A NUMBER. THIS TASK IS ASSIGNED TO SCREW, 4. THIS SCREW HAS BEEN BROKEN AT THE SHAFT TO A LENGTH OF 27.73. IT APPEARS TO BE OF THE 204.810 FAMILY OF PARTS. THE BROKEN SHAFT PRECLUDES POSITIVE IDENTIFICATION WITHIN THE PART FAMILY. THE DRIVE HAS BEEN SLIGHTLY DAMAGED, CONSISTENT WITH USE. THE TOP OF THE HEAD HAS WHAT APPEARS TO BE ABRASION MARKS. THE BOTTOM OF THE HEAD HAS A SINGLE CONTACT MARK WITH SLIGHT WEAR, MATERIAL REMOVAL. THE SHAFT THREADS HAVE BEEN COMPRESSED INTO THE SHAPE OF A T AT THE MAJOR DIAMETER THE ENTIRE LENGTH OF THE REMAINING SHAFT. THERE ARE NO FLUTES AND TIP, END OF THE PART HAS BEEN BROKEN OFF. BECAUSE OF THE TYPE AND EXTENT OF DAMAGE INCURRED NO FURTHER EVALUATION CAN BE PERFORMED. THE TWO INDEPENDENT SCREWS WHICH BROKE ARE 4.0MM CANCELLOUS SCREWS. THESE SCREWS HAVE AN ADEQUATE DESIGN. THE RISK ANALYSIS WAS REVIEWED AND DOES ADEQUATELY ADDRESS THE COMPLAINT EVENT ON. AN ASSESSMENT ON IF ANY TRENDS ARE APPARENT CANNOT BE COMPLETED SINCE IT IS NOT KNOWN EXACTLY WHAT PART NUMBERS THESE 2 SCREWS ARE, SINCE ONLY THE SCREW HEADS WITH PARTIAL SHAFTS WERE RETRIEVED AND RETURNED. FROM THE COMPLAINT DESCRIPTION, IT IS NOT POSSIBLE TO DETERMINE THE LOADING ON THE SCREWS DURING PATIENT HEALING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. ADDITIONAL INFORMATION: DATE OF REPORT: (B)(4) 2012, DEVICE INFO: SYNTHES LOCKING PLATE/ 8 SCREWS, LOCKING PLATE AND SCREWS, RETURNED TO MANUFACTURER ON: (B)(4) 2012.

    Description of Event or Problem · 1

    THIS REPORT IS #5 OF 9 FOR THE SAME EVENT. PATIENT HAD SURGERY ON HER RIGHT ANKLE (B)(6) 2012 FOR "BURSITIS SECONDARY TO DEEP IMPLANT" FROM A PREVIOUS IMPLANTATION OF THE HARDWARE (B)(6) 2010. ON (B)(6) 2010, THE PATIENT HAD THE PROCEDURE OF "OPEN REDUCTION INTERNAL FIXATION RIGHT ANKLE TRIMALLEOLAR FRACTURE." DURING THE PROCEDURE 2 CORTICAL SCREWS WERE PLACED OBLIQUELY ACROSS THE FRACTURE MAINTAINING ANATOMIC REDUCTION. THE FIBULA FRACTURE WAS EXPOSED AND REDUCED ANATOMICALLY AND A 6-HOLE LOCKING PLATE WAS APPLIED USING A COMBINATION OF BOTH LOCKING AND UNLOCKING SCREWS. THE SURGERY WAS REPORTED AS NO COMPLICATIONS. ON (B)(6)2012, THE PATIENT CHOSE ELECTIVE SURGERY TO REMOVE THE HARDWARE AND SCREWS RELATED TO BURSITIS SECONDARY TO THE DEEP IMPLANT. TOTAL OF 8 SCREWS AND THE LOCKING PLATE WERE REMOVED. AFTER REMOVAL OF THE TWO SMALL FRAGMENT SCREWS, THE SCREWS WERE NOTED BY THE SURGEON TO BE BROKEN. THE INTRAOSSEOUS METALLIC SEGMENTS OF THE SCREWS WERE NOT REMOVED BY THE SURGEON. AFTER REMOVED OF THE OTHER SCREWS, THERE WAS THE SYNDESMOSIS SCREW THAT WAS PREVIOUSLY NOTED TO BE BROKEN AND THIS WAS NOT REMOVED. THE SURGEON THEN RONGEURED THE SCREW HOLES AND CLOSED THE WOUND WITH A DRESSING APPLIED. THE PLATE AND 8 TOTAL SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM CORTEX SCREW SLF TPING 14MM CORTEX SCREW HRS SYNTHES, INC. 223561 UK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R SCREWS| PLATE