BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/LT

    MDR report key: 5091878 · Received September 21, 2015

    Report

    Report Number
    2520274-2015-16029
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK110125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT WAS REPORTED AS (B)(6). PATIENT IDENTIFIER IS UNKNOWN. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RECEIVED FOR MANUFACTURING REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT THE: THE DHR OF LOT 9223308 WAS REVIEWED: NO NCRS GENERATED DURING PRODUCTION, THERE ARE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RETURNED PART HAS BEEN IDENTIFIED, THE PLATE GEOMETRY CORRESPONDS TO ARTICLE 04.115.751. AN ADDITIONAL FRAGMENT WHICH COULD NOT BE IDENTIFIED AND NOT BELONGING TO THE COMPLAINED PLATE WAS ALSO RECEIVED. PLATE IS FRACTURED AT LEVEL OF VARIABLE ANGLE HOLE VA7. NO DIMENSIONAL INSPECTION COULD HAVE BEEN PERFORMED IN THE FRACTURED AREA DUE TO DEFORMATION. VA3, VA10 AND VA11 HAVE BEEN MEASURED AND FOUND CONFORMING TO SPECIFICATION, CONSIDERING THAT HOLES VA1 TO VA11 ARE MANUFACTURED WITH THE SAME PARAMETERS AND TOOLS, THE HOLE VA7 CAN BE CONSIDERED CONFORMING TO SPECIFICATION AS WELL. COMPLAINT IS CONFIMED DUE TO THE EVIDENCE THAT THE PLATE IS BROKEN BUT THE ISSUE IS NOT VALID FOR (B)(4) BECAUSE THE COMPLAINED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. ADDITIONAL COMPLAINT INVESTIGATION REQUEST SUBMITTED TO CHU INDICATE THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION. DUE TO POST PRODUCTION WEAR AND DEFORMATION IN THE FRACTURE REGION NO DIMENSIONAL INSPECTION COULD BE PERFORMED. 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

    (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 31OCTOBER2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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 A PATIENT UNDERWENT AN OSTEOTOMY PROCEDURE ON (B)(6) 2015 DUE TO A BONE MAL-UNION. THE SURGEON PLANNED TO IMPLANT A 2.4MM TITANIUM VARIABLE-ANGLE LOCKING COMPRESSION PLATE (TI VA-LCP). IN ORDER TO DO SO, THE SURGEON HAD TO SLIGHTLY BEND THE PLATE TO FIT THE PATIENT'S BONE ANATOMY; THE PLATE IMMEDIATELY BROKE. A SIMILAR PLATE WAS ON HAND TO COMPLETE THE PROCEDURE. A TWENTY (20) MINUTE DELAY WAS NOTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621834 2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/LT PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 9223308

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR