BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI QUARTER-TUBULAR PLATE WITH COLLAR 7 HOLES/55MM

    MDR report key: 7156711 · Received January 2, 2018

    Report

    Report Number
    8030965-2018-50001
    Event Type
    Injury
    Date Received
    January 2, 2018
    Report Date
    December 4, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819203518
    PMA / PMN Number
    PREAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: DHR REVIEW WAS COMPLETED. PART NUMBER: 442.070 . SYNTHES LOT NUMBER: L277300 . RELEASE TO WAREHOUSE DATE: 23.JAN.2017 . MANUFACTURING SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. 1X ARTICLE 442.070 WITH LOT L277300 / TI QUARTER-TUBULAR PLATE WITH COLLAR 7 HOLES/55MM RECEIVED AND FORWARDED TO MANUFACTURING PLANT (B)(4) FOR INVESTIGATION: AS RECEIVED CONDITION OF DEVICE: THE PLATE IS BROKEN AT HOLE 5 (COUNTED FROM THE RIGHT SIDE). IT HAS SEVERAL SCRATCHES ON THE SURFACE. FURTHER THERE ARE SEVERAL ABRASIONS AND INJURIES ON THE SURFACE AND WITHIN HOLES. THE LASER MARKING IS READABLE AND THE PLATE WAS RETURNED IN PACKAGING DIFFERENT FROM THE ORIGINAL ONE. A DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT L227300 / ARTICLE 442.070 WHICH INCLUDES THE FINISH GOOD PRODUCT AND ITS COMPONENTS. THE INITIAL AND FINAL LOT SIZE WAS (B)(4) PIECES; THERE WAS NO SCRAP. NO ABNORMALITIES OR DEVIATIONS WERE DETECTED NEITHER NCS WERE TRIGGERED WHICH COULD LEAD TO THE COMPLAINT FAILURE. DIMENSIONAL: ALL DIMENSIONS OF THE PLATE RECEIVED WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION WERE MEASURED, AND HAVE FULFILLED THEIR SPECIFICATIONS ACCORDING TO THE DRAWING. AS WELL AS, THICKNESS WAS MEASURED CLOSE TO THE BREAKAGE POINT AND HAS PASSED ITS SPECIFICATIONS. BESIDES, DURING MANUFACTURING PROCESS THE LOT RELATED TO THIS COMPLAINT WAS INSPECTED REGARDING TO ITS DIMENSIONAL FEATURES SUCH AS COLLAR HEIGHT AND DISTANCE THROUGH THE INSPECTION SHEET AND THE WHOLE LOT HAS PASSED ITS SPECIFICATIONS. THEREFORE, THIS PLATE WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND A MANUFACTURING ISSUE CAN BE EXCLUDED. MATERIAL: THE RAW MATERIAL CERTIFICATES WERE CHECKED AND IT WAS FOUND THAT ALL USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. DISPOSITIONS: BASED ON THE INVESTIGATION RESULTS, THIS COMPLAINT IS RATED AS CONFIRMED BECAUSE THE PLATE IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, THIS COMPLAINT IS RATED NOT VALID FROM THE MANUFACTURING POINT OF VIEW SINCE NO DEVIATIONS WERE FOUND IN THE MANUFACTURING DOCUMENTATION AS WELL AS DURING THIS INVESTIGATION ALL RELEVANT MEASUREMENTS PERFORMED ARE ACCORDING TO THE MANUFACTURING SPECIFICATIONS. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CORRECTED DATA: CONCOMITANT DEVICES UPDATED. 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 · 0

    CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW 14MM (402.014, LOT L151525, QUANTITY 2), 2.7MM CORTEX SCREW 14MM (402.014, LOT L392860, QUANTITY 1), 2.7MM CORTEX SCREW 20MM (402.020, LOT L386761, QUANTITY 1), 2.7MM CORTEX SCREW 22MM (402.022, LOT 8291353, QUANTITY 1), 2.7MM CORTEX SCREW 16MM (402.016S, LOT L406046, QUANTITY 1)

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 REPORTED THAT ON UNKNOWN DATE IN 2011, WHEN THE PATIENT WAS (B)(6), SHE HAD SUFFERED FROM MONTEGGIA FRACTURE. ON (B)(6) 2017, THE PATIENT, WHO IS NOW (B)(6), UNDERWENT ULNA-CORRECTION OSTEOTOMY. THE PURPOSE OF THIS SURGERY WAS TO CURE THE RADIAL HEAD DISLOCATION DUE TO THE DEFORMED BONE ADHESION. IN THIS SURGERY, THE QUARTER TUBULAR PLATE WAS USED FOR THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. WHILE PATIENT WAS HOSPITALIZED, A CAST WAS APPLIED FROM THE WRIST THROUGH HUMERUS. ON (B)(6) 2017, THERE WAS NO APPARENT ABNORMALITIES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DURING A FOLLOW UP VISIT ON (B)(6) 2017, IT WAS FOUND THE REPORTED PLATE HAD BEEN BROKEN. THE SURGEON OPTED TO OBSERVE THE PATIENT¿S STATUS BECAUSE IT WAS NOT FOUND DISLOCATION. ON (B)(6) 2017, IT WAS FOUND THAT THE AREA OF THE OSTEOTOMY HAD MOVED AND THE CORRECTION HAD DEFORMED. ON (B)(6) 2017, THE EXPLANT SURGERY WAS PERFORMED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. A REVISION TO A LOCKING COMPRESSION PLATE (LCP) OR VARIABLE ANGLE (VA) OLECRANON WAS PLANNED FOR (B)(6) 2017. IT IS NOT KNOWN IF THE REVISION TOOK PLACE. THE SURGEON REPORTED PATIENT HAS INSENSITIVITY TO PAIN WITH ANHIDROSIS, WHICH MAY HAVE RESULTED IN IMPROPER POSTOPERATIVE COMPLIANCE. SURGEON ALSO REPORTS THE PLATE WAS BENT PRIOR TO INSERTION, SO THE PLATE COULD NOT BEAR THE BREAKAGE STRESS. CONCOMITANT DEVICES REPORTED: 2.7MM TITANIUM CORTEX SCREW 14MM (402.014S, LOT L392860, QUANTITY 1), 2.7MM TITANIUM CORTEX SCREW 14MM (402.014S, LOT L151525, QUANTITY 2),2.7MM TITANIUM CORTEX SCREW 16MM (402.016S, LOT L406046, QUANTITY 1), 2.7MM TITANIUM CORTEX SCREW 20MM (402.020S, LOT L386761, QUANTITY 1), 2.7MM TITANIUM CORTEX SCREW 22MM (402.022S, LOT 8291353, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533 TI QUARTER-TUBULAR PLATE WITH COLLAR 7 HOLES/55MM PLATE, FIXATION, BONE HRS OBERDORF : SYNTHES PRODUKTIONS GMBH L277300 07611819203518

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention