BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5340735 · Received January 4, 2016

    Report

    Report Number
    2520274-2016-10004
    Event Type
    Injury
    Date Received
    January 4, 2016
    Report Date
    December 11, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN. IT WAS REPORTED BY THE PATIENT THAT THE PLATE BROKE ON NOVEMBER 6, 2014; HOWEVER, IT IS UNKNOWN IF THIS IS THE ACTUAL DATE THE PLATE BROKE AND IF THE SCREWS BROKE ON THIS DATE. THE 510(K): THE FOLLOWING PART AND LOT NUMBERS WERE PROVIDED BY THE REPORTER HOWEVER, IT IS UNKNOWN WHICH OF THE FOLLOWING DEVICES WERE BROKEN: ONE (1) EACH, PART NUMBER 04.120.605, LOT NUMBER 8588807, TI CONNECTING SCREW FOR LOCKING ATTACHMENT PLATE, DEVICE PRODUCT CODE¿HRS, COMMON NAME¿PLATE, FIXATION BONE, 510(K) K083573. ONE (1) EACH, PART NUMBER 04.120.602, LOT NUMBER 8916619, 3.5MM TI LCKNG ATTACHMENT PL FOR 4.5MM LCP PLATE/8 HOLE, DEVICE PRODUCT CODE¿HRS, COMMON NAME¿PLATE, FIXATION BONE, 510(K) K083573. ONE (1) EACH, PART NUMBER 04.120.602, LOT NUMBER 8581541, 3.5MM TI LCKNG ATTACHMENT PL FOR 4.5MM LCP PLATE/8 HOLE, DEVICE PRODUCT CODE¿HRS, COMMON NAME¿PLATE, FIXATION BONE, 510(K) K083573. TWO (2) EACH UNKNOWN SCREWS. DEVICE PRODUCT CODE¿HWC, COMMON NAME¿SCREW, FIXATION, BONE. ONE (1) EACH, UNKNOWN PART NUMBER, LOT NUMBER 2781946. ONE (1) EACH, PART NUMBER 404.834, LOT NUMBER 8705524, 3.5MM TI CORTEX SCREW SELF-TAPPING 34MM, DEVICE PRODUCT CODES¿HRS AND HWC, COMMON NAME¿PLATE, FIXATION BONE, 510(K) K131186. ONE (1) EACH, PRODUCT NUMBER 413.322 , LOT NUMBER 2654776, LOCKING SCREW WITH HEX DRIVE, SELF-TAPPING, 22MM. DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL. THE 510(K)¿ DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. ONE (1) EACH, PRODUCT NUMBER 413.038, LOT NUMBER 8886893, 3.5MM TI LOCKING SCREW SELF-TAPPING 38MM, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) K000684. ONE (1) EACH, UNKNOWN PART NUMBER, LOT NUMBER 8589871. UNKNOWN LOCKING SCREW. ONE (1) EACH, UNKNOWN PART NUMBER, LOT NUMBER 8833523. UNKNOWN LOCKING SCREW. ONE (1) EACH, UNKNOWN PART NUMBER, LOT NUMBER 8722676. UNKNOWN LOCKING SCREW. ONE (1) EACH, 222.404, LOT NUMBER 2737526, 5.0MM PERIPROSTHETIC LCKNG SCR SELF-TAPPING 18MM, DEVICE PRODUCT CODE¿HWC, COMMON NAME¿SCREW, FIXATION, BONE. ONE (1) EACH, 213.336, LOT NUMBER 8511064, 5.0MM LOCKING SCREW SELF-TAPPING 36MM, DEVICE PRODUCT CODES¿KTT, HWC, COMMON NAME¿APPLIANCE, FIXATION, NAIL. THE 510(K) K000682. ONE (1) EACH, 213.338, LOT NUMBER 8058493, 5.0MM LOCKING SCREW SELF-TAPPING 38MM, DEVICE PRODUCT CODES¿KTT, HWC, COMMON NAME¿APPLIANCE, FIXATION, NAIL. 510(K) K000682. ONE (1) EACH, 213.340, LOT NUMBER 8932829, 5.0MM LOCKING SCREW SELF-TAPPING 40MM, DEVICE PRODUCT CODES¿KTT, HWC, COMMON NAME¿APPLIANCE, FIXATION, NAIL. 510(K) K000682. ONE (1) EACH, 213.346, LOT NUMBER UNKNOWN, 5.0MM LOCKING SCREW SELF-TAPPING 46MM, DEVICE PRODUCT CODES¿KTT, HWC, COMMON NAME¿APPLIANCE, FIXATION, NAIL. 510(K) K000682. ONE (1) EACH, 213.355, LOT NUMBER UNKNOWN, 5.0MM LOCKING SCREW SELF-TAPPING 55MM, DEVICE PRODUCT CODES¿KTT, HWC, COMMON NAME¿APPLIANCE, FIXATION, NAIL. 510(K) K000682. OTHER¿UDI UNKNOWN FOR DEVICES AT THIS TIME. DATE OF EXPLANT IS UNKNOWN. (B)(6). THE SUBJECT DEVICES ARE EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE MATERIAL THAT THE SCREWS WERE NOT BROKEN. THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE, THERE IS NO REPORTED MALFUNCTION OR ADVERSE EVENT CAUSED OR CONTRIBUTED TO WITH THIS DEVICE. THE DEVICE FUNCTIONED AS INTENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FROM INVESTIGATION OR BY OTHER MEANS, THIS DETERMINATION SHOULD BE SENT BACK FOR CLINICIAN REVIEW. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS INITIALLY REPORTED TO SYNTHES ON (B)(6) 2015 THAT A PLATE BROKE POSTOPERATIVELY AND REQUIRED REVISION/EXPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 11, 2015. AN UPDATED DEVICE REPORT ALONG WITH PHOTOGRAPHS OF THE EXPLANTED DEVICES WERE RECEIVED. THE PHOTOGRAPHS INDICATE THAT THERE MAY BE AN UNKNOWN QUANTITY OF BROKEN SCREWS. PART AND LOT NUMBERS OF THE EXPLANTED DEVICES WERE PROVIDED IN THE UPDATED DEVICE REPORT; HOWEVER, IT IS UNKNOWN AT THIS TIME WHICH AND HOW MANY OF THE SCREWS MAY HAVE BROKEN POST-OPERATIVELY OR DURING REMOVAL OF THE PLATE. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION SURGERY ON (B)(6) 2014 (ADDRESSED AND REPORTED SEPARATED IN RELATED (B)(4)) TO REMOVE A BROKEN PLATE AND TO ADDRESS NON-UNION. DURING THIS SURGERY, A NEW LOCKING COMPRESSION PROXIMAL FEMUR PLATE 16-HOLE (LEFT) WAS IMPLANTED ALONG WITH ADDITIONAL FIXATION EXTENSIONS. THE SURGEON NOTED THAT THE PATIENT HAS POOR BONE BIOLOGY. ON THE EVENING OF (B)(6) 2014, IT WAS REPORTED BY THE PATIENT THAT THIS SECOND PLATE BROKE WHILE SHE WAS LYING IN BED; HOWEVER, IT WAS NOT CONFIRMED BY THE SURGEON THAT THE PLATE ACTUALLY BROKE ON THIS DATE. IT WAS REPORTED BY THE SURGEON THAT THE PATIENT'S BONE AGAIN HAD FAILED TO HEAL SUFFICIENTLY AND IN HIS OPINION, THE PATIENT'S BIOLOGY CONTRIBUTED TO THE FRACTURE OF THE SECOND PLATE. THE SECOND PLATE AND HARDWARE WERE REMOVED DURING A SECOND REVISION SURGERY ON AN UNKNOWN DATE. ADDITIONAL DETAILS REGARDING FURTHER REVISION AND TREATMENT WERE NOT PROVIDED BY THE SURGEON. THIS REPORT ADDRESSES THE SCREWS IMPLANTED ON (B)(6) 2014 AND THE SUBSEQUENT BREAKAGE, NON-UNION AND REVISION/EXPLANT SURGERY. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS WHICH WERE REPORTED TO HAVE BROKEN. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPON RECEIPT OF THE MATERIAL THAT THE SCREWS WERE NOT BROKEN. THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE, THERE IS NO REPORTED MALFUNCTION OR ADVERSE EVENT CAUSED OR CONTRIBUTED TO WITH THIS DEVICE. THE DEVICE FUNCTIONED AS INTENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FROM INVESTIGATION OR BY OTHER MEANS, THIS DETERMINATION SHOULD BE SENT BACK FOR CLINICIAN REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention