BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 6 HOLES 85MM

    MDR report key: 2810058 · Received October 18, 2012

    Report

    Report Number
    3003506883-2012-00326
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 19, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ADDITIONAL INFORMATION: DATE OF REPORT: (B)(4) 2012, DEVICE INFO: SYNTHES LOCKING PLATE/ 8 SCREWS, LOCKING PLATE AND SCREWS, DEVICE MFR: SYNTHES, INC, (B)(4). RETURNED TO MANUFACTURER ON: (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. THE AS RECEIVED CONDITION OF THE PLATE WAS INTACT WITH SOME MARKING/SCRATCHING CONSISTENT WILL NORMAL FIELD USAGE. ALL RELATED PERTINENT DIMENSIONAL FEATURES WERE OBTAINABLE, MEASURED AND PASSED. MATERIAL TESTING WAS CONDUCTED ON THE RETURNED PART USING XRFA AND WAS CONFIRMED TO BE 316L STAINLESS STEEL. INSPECTION, MEASUREMENT OF THE RETURNED PART SHOWED THAT IT MEETS ALL DIMENSIONAL AND VISUAL REQUIREMENTS FOR PERTINENT FEATURES THAT COULD BE RELATED TO THE CUSTOMER COMPLAINT. 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.

    Description of Event or Problem · 1

    THIS REPORT IS #1 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 LCP PLATE 6 HOLES 85MM 3.5MM LCP PLATE 6 HOLES 85MM HRS SYNTHES ELMIRA 223561 6083469

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R