BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM LCP CONDYLAR PLATE 6 HOLE SHAFT

    MDR report key: 7779225 · Received August 13, 2018

    Report

    Report Number
    8030965-2018-55697
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 28, 2018
    Report Date
    July 29, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    10886982034922
    PMA / PMN Number
    K090047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THREE PLATES WERE INVOLVED IN THE EVENT AND WERE RETURNED. PER DESIGN, THE PLATES ARE NOT ETCHED WITH LOT NUMBERS, THEREFORE, THIS INVESTIGATION CONTAINS RESULTS FOR ALL THREE PLATES. VISUAL INSPECTION OF THE RETURNED PLATES REVEALED STRIPPING OF THE THREAD-STARTS OF ALL HOLES FOR ALL PLATES. ONE PLATE¿S PLATE HEAD WAS RECEIVED BENT: THE TWO OUTER EDGES OF THE HEAD¿S TANGS WERE BENT DOWNWARD, AS IF THEY WERE BEING CONTOURED TO THE BONE. ANOTHER PLATE WAS RECEIVED WITH A SLIGHT BEND LONGITUDINALLY. THE THIRD PLATE WAS RECEIVED WITH NO VISIBLE BEND. THE COMPLAINT CONDITION SPECIFIES THAT THE ISSUE OF ¿UNABLE TO ASSEMBLE¿ OCCURRED DURING PLATE BENDING, WHICH IS AN INTENDED USE OF THE PLATE DESCRIBED IN TECHNIQUE GUIDES. THEREFORE, NO ISSUE HAS BEEN IDENTIFIED REGARDING THE PLATES¿ BENDING. FUNCTIONAL TEST: FUNCTIONAL TESTING WITH THE TWO RETURNED BENDING PINS (03.114.003/LOT H299829) AND TWO LOCKING SCREWS (02.214.012/LOTS 7086832 AND 7815462) WAS PERFORMED. DIFFICULTY ENGAGING THE THREADS OF THE BENDING PINS AND LOCKING SCREWS WAS EXPERIENCED WITH ALL PLATES IN ALL HOLES. THE RECEIVED CONDITION FOR ALL THREE PLATES AGREES WITH THE COMPLAINT DESCRIPTION ¿ THE COMPLAINT WAS REPLICATED WITH THE RETURNED DEVICES. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DEVICE HISTORY RECORD(S) FOR LOTS 9935795 AND H322156 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE LOT NUMBER WAS UNKNOWN FOR THE THIRD PLATE, THEREFORE REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE RELEVANT DRAWINGS WERE REVIEWED: (CURRENT AT THE TIME OF MANUFACTURE AND INVESTIGATION FOR THE TWO PLATES WITH KNOWN LOT NUMBERS; AS THE LOT NUMBER WAS UNKNOWN FOR THE THIRD PLATE, THE DRAWING USED AT THE TIME OF MANUFACTURER COULD NOT BE DETERMINED). DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED WITH INVESTIGATION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION OF THE RETURNED DEVICE REVEALED NO NON-CONFORMANCES OF THE DEVICE¿S GEOMETRIC SPECIFICATIONS. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT OFF AXIS THREAD-ENGAGEMENT BETWEEN THE BENDING PINS AND PLATES STRIPPED THE PLATES¿ THREAD-STARTS. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR DISTAL RADIUS FRACTURES ON (B)(6) 2018. DURING THE PROCEDURE, SURGEON ATTACHED TWO (2) BENDING PINS TO A PLATE, THEN TRIED TO CONTOUR THE PLATE USING THE BENDING PINS. HOWEVER, THE BENDING PINS CAME OFF THE PLATE WHILE BENDING. SURGEON ATTEMPTED TO USE TWO (2) OTHER PLATES BUT OBTAINED THE SAME RESULTS. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE, A LOCKING SCREW WOULD NOT LOCK TO THE PLATES. SURGEON WAS NOT SURE IF THE ISSUE WAS DUE TO THE BENDING PINS OR THE SCREW HOLE ON THE PLATES. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES AND NO REPORTED CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) 1.5MM LCP CONDYLAR PLATE. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618378 1.5MM LCP CONDYLAR PLATE 6 HOLE SHAFT PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 02.114.014 24089810 10886982034922

    Patients

    Seq Age Sex Outcome Treatment
    1