BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5923468 · Received September 1, 2016

    Report

    Report Number
    2520274-2016-14419
    Event Type
    Injury
    Date Received
    September 1, 2016
    Report Date
    April 22, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. H10 ADDITIONAL NARRATIVE: PATIENT HEIGHT IS 5 FEET, 7 INCHES. EVENT DATE: UNKNOWN. PMA 510(K): THIS REPORT IS FOR TWO (2) UNKNOWN SCREWS (BROKEN POSTOPERATIVELY). OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. BASED ON THE MANUFACTURER¿S INVESTIGATION IT IS POSSIBLE THAT THE TWO RECEIVED BROKEN SCREWS MAY BE AS FOLLOWS: PART NUMBER 207.045, 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM, LOT NUMBER UNKNOWN, 510 (K) K083213, COMMON NAME PLATE, FIXATION, BONE, DEVICE PRODUCT CODES HRS AND HWC; AND PART NUMBER 204.830, 3.5MM CORTEX SCREW SELF-TAPPING 30MM, 510 (K) K112583, COMMON NAME SCREW, FIXATION, BONE, DEVICE PRODUCT CODE HWC. (B)(4). A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE TWO UNKNOWN SCREWS. BASED ON THE INVESTIGATION, THE FOLLOWING PART NUMBERS WERE DETERMINED TO BE THE MOST LIKELY FOR THE TWO SCREWS RECEIVED IN A BROKEN CONDITION: PART NUMBER: 207.045, MEASURED LENGTH 45.71 MM, AND PART NUMBER: 204.830, MEASURED LENGTH: 14.44MM. THE RETURNED SCREWS (PART NUMBERS: 207.045 AND 204.830) ARE PART OF THE DEPUY SYNTHES SMALL FRAGMENT LOCKING COMPRESSION PLATE SYSTEM PER THE TECHNIQUE GUIDE. UPON VISUAL INSPECTION IT CAN BE SEEN THAT BOTH SCREWS FRACTURED SLIGHTLY BELOW THE SCREW HEAD. THE BALANCE OF THE IMPLANTS IS IN FAIR CONDITION AND SHOWING SIGNS OF BEING IMPLANTED/EXTRACTED. DRAWINGS WERE REVIEWED DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE DONE ON BOTH BROKEN SCREWS AS THE LOT NUMBERS ARE UNKNOWN. THE COMPLAINT CONDITION WAS CONFIRMED. WHEN THERE IS INSUFFICIENT REDUCTION OR HEALING IS DELAYED THERE ARE INCREASED LOADS THE IMPLANT MUST WITHSTAND, THAT WOULD NORMALLY BE SUPPORTED BY THE BONE, WHICH COULD EVENTUALLY CAUSE IT TO BREAK DUE TO METAL FATIGUE. THIS IS FURTHER IMPACTED BY PATIENT COMPLIANCE AND ACTIVITY LEVEL, COMORBIDITIES, AND THE SURGICAL TECHNIQUE. THUS, SINCE THE CONDITIONS AT THE TIME OF THE BREAK ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 INITIALLY REPORTED THAT ON (B)(6) 2015 THE PATIENT WAS IMPLANTED WITH THREE (3) UNKNOWN PLATES AND AN UNKNOWN NUMBER OF SCREWS TO REPAIR THE TIBIA AND FIBULA. IN (B)(6) 2015 AN INFECTION WAS DIAGNOSED, HOWEVER HE DID NOT RECEIVE TREATMENT UNTIL (B)(6) 2016. THE PATIENT IS SCHEDULED TENTATIVELY FOR EXPLANTATION SURGERY IN 6-7 WEEKS WHEN THE SURGEON FELT HE WAS HEALED. THE PATIENT DID STATE THAT HE HAD AN INFECTION FIVE (5) DAYS PRIOR TO SURGERY, BUT WAS CLEARED BY THE SURGEON TO MOVE FORWARD WITH SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 13, 2016 AND AUGUST 31, 2016 FURTHER REPORTING THAT EXPLANT SURGERY WAS PERFORMED ON (B)(6) 2016. IT WAS CLARIFIED THAT THE PATIENT HAD TWO (2) PLATES AND AN UNKNOWN QUANTITY OF SCREWS INITIALLY IMPLANTED ON (B)(6) 2015 AND SUBSEQUENTLY REMOVED DURING THE (B)(6) 2016 SURGERY. IT WAS DISCOVERED THAT TWO (2) OF THE SCREWS WERE FOUND TO BE BROKEN AND THAT THERE WAS A SURGICAL DELAY OF UNKNOWN DURATION DUE TO THE TIME IT TOOK FOR THE SURGEON TO REMOVE THE SCREW FRAGMENTS. THE PATIENT STATED THAT A FOLLOW-UP X-RAY WAS PERFORMED ON (B)(6) 2016 WHICH REVEALED A THIN CIRCULAR METAL FRAGMENT RETAINED IN HIS BONE. FOURTEEN (14) SCREWS WERE RECEIVED BY THE MANUFACTURER FOR INVESTIGATION ON AUGUST 23, 2016, BUT IT IS UNKNOWN IF THIS WAS ALL OF THE SCREWS ORIGINALLY IMPLANTED IN THE PATIENT. THIS REPORT IS FOR TWO (2) UNKNOWN SCREWS (BROKEN POSTOPERATIVELY). THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573552 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention