BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5173971 · Received October 24, 2015

    Report

    Report Number
    2520274-2015-16812
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Report Date
    October 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THREE (3) UNKNOWN BROKEN SCREWS WITH POTENTIAL PART NUMBERS AS FOLLOWS: PART 04.210.116S: 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE ¿ HRS: PLATE, FIXATION, BONE ¿ K102694. PART 412.818S: 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM ¿ HRS: PLATE, FIXATION, BONE / HWC: SCREW, FIXATION, BONE ¿ K103243. PART 412.816S: 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM ¿ HRS: PLATE, FIXATION, BONE / HWC: SCREW, FIXATION, BONE ¿ K103243. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. WITHOUT VERIFICATION OF PART AND LOT NUMBERS, A UDI IS NOT AVAILABLE. PRODUCT INVESTIGATION SUMMARY: THE COMPLETED VISUAL INSPECTION SHOWS THAT THE PLATE HAS SOME DENTS, SCRATCHES, AND MARKS OF USE ON THE OUTSIDE SURFACE. ALSO, THE INSIDE THREADS IN THE PLATE HOLES ARE SLIGHTLY WORN. THE FOUR (4) UNKNOWN SCREWS, WHERE THE HEADS ARE BROKEN AWAY FROM THE SHAFT, ALL SHOW DAMAGES AND WORN SHAFT THREADS. ONE OF THE SIX (6) RECEIVED SCREWS (PART 412.816S) AND UNKNOWN GREEN ANODIZED SCREW WERE SLIGHTLY USED, BUT OTHERWISE NOT DAMAGED. IT IS LIKELY THAT THE FRACTURE MUST HAVE BEEN DUE TO THE MOTION AND CHANGING POSITION OF THE PLATE. THIS LIKELY CAUSED THE SHEARING FORCE, WHICH MUST HAVE CAUSED THE OVERLOADING SITUATION AND THE BREAKING OF THE SCREW HEADS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SCREWS COULD NOT BE CONDUCTED DUE TO THE MISSING LOT NUMBERS. NO INDICATION FOR MATERIAL OR DESIGN RELATED ISSUE WAS FOUND. DEVICE 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

    THE REVISION SURGERY AND X-RAYS WERE PLANNED TREATMENTS AND WERE NOT THE RESULT OF THE DEVICE MALFUNCTION. THEREFORE, THIS REPORT IS DETERMINED TO BE A REPORTABLE MALFUNCTION (PRODUCT PROBLEM), NOT RELATED TO A SERIOUS INJURY. THIS REPORT IS FOR FOUR (4) UNKNOWN BROKEN 2.4MM LOCKING SCREWS. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. HOSPITAL CONTACT NUMBER: (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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

    THIS REPORT IS FOR THREE (3) UNKNOWN BROKEN SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS ORIGINALLY IMPLANTED WITH A VARIABLE ANGLE- TWO COLUMN PLATE (VA-TCP) ON (B)(6) 2015 TO TREAT A DISTAL RADIUS FRACTURE. APPROXIMATELY ONE (1) WEEK LATER, THE PATIENT WAS TREATED WITH FIXATION OF SPRINT AND REHAB. AFTER TWO (2) WEEKS OF IMPLANTATION, THE PATIENT'S BONE SEEMED TO BE FULLY HEALED. HOWEVER, X-RAY IMAGING SUGGESTED THAT THE ANGLE OF THE IMPLANTED SCREWS HAD SHIFTED INTO A DIRECTION DIFFERENT FROM THAT OF INSERTION. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2015 FOR AN EXPLANT PROCEDURE DUE TO SUCCESSFUL BONE UNION. DURING THE SURGERY, FOUR (4) OF THE ORIGINALLY IMPLANTED LOCKING SCREWS WERE DISCOVERED TO BE BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF PROLONGATION. THIS REPORT IS FOR THE FOUR (4) UNKNOWN BROKEN 2.4MM LOCKING SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702808 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1