BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LCP PLATE 12 HOLE/157MM

    MDR report key: 6689360 · Received July 6, 2017

    Report

    Report Number
    2520274-2017-11918
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Report Date
    June 12, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERAPY DATE IS UNKNOWN. REPORTER PHONE NUMBER: (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # VP4041.12, LOT # H200382: PRODUCT MANUFACTURE DATE: 11-OCT-2016, PRODUCT MANUFACTURE LOCATION: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE (DHR) SHOWS THIS LOT OF 3.5MM LCP PLATE 12 HOLES/157MM (PART NUMBER VP4041.12, LOT NUMBER H200382) WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING COMPRESSION VETERINARY PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. 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

    MANUFACTURING EVALUATION WAS COMPLETED. A VISUAL INSPECTION SHOWS THE PART IS BROKEN INTO TWO PIECES. THE BREAK RUNS DIRECTLY THROUGH THE SIXTH HOLE FROM THE STACKED HOLE PER INSPECTION SHEET. MARKS AND SCRATCHES ARE PRESENT ON TOP AND BOTTOM SURFACES. THE MANUFACTURING REVIEW DOES SHOW THAT THE PRODUCTION PROCEDURE WAS PER THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. ALL DIMENSIONS WHICH ARE RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED AND WERE FOUND IN COMPLIANCE WITH THE TECHNICAL SPECIFICATIONS. DIMENSIONAL FEATURES AT HOLE 6 WERE NOT OBTAINED DUE TO THE PLATE BEING DAMAGED. DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION LEAD TO THE BREAKAGE. BASED ON THE INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN 3.5MM LOCKING COMPRESSION VETERINARY PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. IT IS UNKNOWN IF THE PLATE BROKE INTRA-OPERATIVELY OR POST-OPERATIVELY. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. THIS REPORT IS FOR ONE (1) UNKNOWN 3.5MM LOCKING COMPRESSION VETERINARY PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT THE PLATE BROKE POST-OPERATIVELY. THE PLATE BROKE AT A HOLE OCCUPIED BY A SCREW. AT THIS POINT, THE METAL HAS A CONVEXITY AROUND THE RUPTURE. IT IS UNKNOWN WHEN THE INITIAL IMPLANTATION SURGERY TOOK PLACE BUT THE REVISION SURGERY WAS PERFORMED ON (B)(6)2017. DURING THE REVISION A NEW LOCKING COMPRESSION PLATE WAS IMPLANTED. PATIENT IS A DOG AND IS DOING FINE NOW. CONCOMITANT DEVICE REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 12) THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 12 HOLE/157MM

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 3.5MM LOCKING COMPRESSION VETERINARY PLATE BROKE. AT THE MOMENT IS NOT KNOWN IF THE PLATE BROKE INTRA-OPERATIVELY OR POST-OPERATIVELY. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS REPORT IS FOR ONE (1) UNKNOWN 3.5MM LOCKING COMPRESSION VETERINARY PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470873 3.5MM LCP PLATE 12 HOLE/157MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA H200382

    Patients

    Seq Age Sex Outcome Treatment
    1