BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM LCP PLATE 9 HOLES/72MM-2.0MM THK

    MDR report key: 4618111 · Received March 19, 2015

    Report

    Report Number
    3003506883-2015-10059
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Report Date
    March 6, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7464838 OF 2.4MM LCP PLATE 9 HOLES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED THE RAW MATERIAL LOT 7232244 MET ALL SPECIFICATIONS. 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. DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. 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

    ADDITIONAL NARRATIVE: DATE OF DEVICE BREAK IS UNKNOWN, BUT SAID TO HAVE OCCURRED APPROXIMATELY 30 DAYS POSTOPERATIVE. PRODUCT INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PLATE THAT BROKE 30 DAYS AFTER SURGERY. REPORTER UPDATED THAT DOG HAD A SURGERY AND WENT THROUGH REHABILITATION. AFTER 30 DAYS, THE PLATE BROKE AND THEY HAD TO HAVE ANOTHER SURGERY. THE 9-HOLE PLATE WAS RECEIVED WITH A TRANSVERSE BREAK IN THE MIDDLE COMBI-HOLE. THERE ALSO EXISTS A 10-20 DEGREE UPWARD BEND AT THE NON-COMBI HOLE END OF THE PLATE. THREE (3) CORTICAL AND FOUR (4) LOCKING SCREWS WERE ALSO RECEIVED, BUT HAVE NO LOT# OR PART # ON THEM TO BE IDENTIFIED FOR EVALUATION PURPOSES. THE SCREWS SHOW NO DAMAGE. THIS COMPLAINT IS CONFIRMED AS THE PLATE WAS RECEIVED BROKEN AS REPORTED. DESIGN EVALUATION: THE ASSOCIATED DRAWING WAS REVIEWED DURING THIS EVALUATION. THE PLATE IS MADE FROM (B)(4) STAINLESS STEEL AND IS 2.0MM THICK. THE LOCATION OF THE PLATE BREAKAGE IS THE MIDDLE COMBI HOLE. NINE (9) COMBI HOLES EXIST IN THIS PLATE FOR PLATE-TO-BONE FIXATION USING SCREWS. SEVEN (7) SCREWS WERE RETURNED WITH THE PLATE. VISUAL EXAMINATION OF WEAR AND NON-WORN AREAS OF THE PLATE SUGGESTS THAT THE COMBI HOLE WHERE THE PLATE BROKE DID NOT HAVE A SCREW INSTALLED. THIS CANNOT BE CONFIRMED AS NO X-RAYS WERE PROVIDED FOR CONSIDERATION. IT IS ALSO UNDERSTOOD THAT THIS HOLE MAY HAVE LINED UP DIRECTLY OVER THE BONE. IN THIS INSTANCE, IN ADDITION TO PLATING, A LAG SCREW TECHNIQUE PERPENDICULAR TO THE FRACTURE MAY HAVE PROVIDED A MORE SUITABLE CONSTRUCT CONSIDERING THE PATIENT IS CANINE, WHICH INTRODUCES ADDITIONAL CONCERNS FOR PATIENT NON-COMPLIANCE. AS A RESULT, THE PLATE BROKE AT THE HOLE WITHOUT A SCREW WHICH IS THE AREA OF LEAST MATERIAL. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT. THE EXACT CAUSE FOR THIS COMPLAINT IS UNDETERMINED, BUT THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS PATIENT NON-COMPLIANCE, WHICH CAN CERTAINLY BE APPRECIATED CONSIDERING THE PATIENT IS CANINE. THIS COMPLAINT COULD NOT BE REPLICATED WITH THE RETURNED PARTS AS THE PLATE WAS RETURNED BROKEN ALREADY. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR A VET CASE. ACTUAL EXPLANT DATE UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    ADDITIONAL INFORMATION REGARDING THE VETERINARY EVENT WAS RECEIVED ON (B)(6) 2015. IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FROM THE PREVIOUS REPAIR. A 12-HOLE 2.7MM SOP PLATE WAS APPLIED LATERALLY AND A 6-HOLE 2.0MM LOCKING COMPRESSION PLATE (LCP) WAS APPLIED CAUDOLATERALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REGARDING A PLATE THAT BROKE 30 DAYS AFTER SURGERY ON (B)(6) 2015 FOR FRACTURE AND WENT THROUGH REHABILITATION. AFTER 30 DAYS, THE DOG HAD TO HAVE ANOTHER SURGERY. ON (B)(6) 2015, AN X-RAY WAS TAKEN AND IT WAS DETERMINED THE IMPLANT FAILED. RADIOLOGY RESULTS OF FEMUR: REVEALED CLOSED SIMPLE TRANSVERSE IMPLANT FAILURE AT SITE OF FRACTURE WITH MEDIAL DISPLACEMENT AND INTERNAL ROTATION OF DISTAL PIECE. IMPLANT FAILURE APPEARS TO BE SITUATED AT THE 5TH SCREW HOLE DOWN THE PLATE AT ORIGINAL FRACTURE SITE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188498 2.4MM LCP PLATE 9 HOLES/72MM-2.0MM THK PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 7464838

    Patients

    Seq Age Sex Outcome Treatment
    1