BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 20 HOLE RECON PLATE 2.5MM THICK

    MDR report key: 5476231 · Received March 3, 2016

    Report

    Report Number
    2520274-2016-11445
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 10, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    PK063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WERE PERFORMED FOR THE SUBJECT DEVICE (TI MATRIXMANDIBLE 20 HOLE RECON PLATE 2.5MM THICK, PART NUMBER 04.503.738, LOT NUMBER 9940504). THE SUBJECT DEVICE WAS RECEIVED WITH THE COMPLAINT DESCRIPTION THAT THE PLATE WAS BENT TOO MANY TIMES DURING MANIPULATION BY THE SURGEON TO SHAPE IT TO THE TEMPLATE, RESULTING IN THE PLATE BREAKING. THE MATRIX-MANDIBLE 2.5MM THICK, 20 HOLE RECONSTRUCTION PLATE (04.503.738S) IS NOTED IN THE MATRIX-MANDIBLE SYSTEM TECHNIQUE GUIDE. THE 2.5MM RECONSTRUCTION PLATES ARE INDICATED FOR PRIMARY MANDIBULAR RECONSTRUCTION, COMMINUTED FRACTURES AND TEMPORARY BRIDGING WITH DELAYED SECONDARY RECONSTRUCTION. STRAIGHT RECONSTRUCTION PLATES ARE SOLD IN TWO LENGTHS (12 AND 20 HOLES) AND IN TWO THICKNESSES (2.5MM AND 2.8MM). RELEVANT DRAWINGS FOR THE RETURNED IMPLANT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9940504 OF MATRIX-MANDIBLE 20 HOLE RECON PLATE 2.5MM THICK WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE PART SCRAPPED AND NO REWORK 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 BILLET MATERIAL LOT 9800911 MET ALL SPECIFICATIONS. THE RETURNED PLATE WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE PLATE WAS FOUND TO BE BROKEN BETWEEN FIFTH AND SIXTH HOLE ON THE LEFT SIDE OF THE PLATE. ADDITIONAL EXAMINATION FINDS THAT THE PLATE WAS CUT DOWN FROM 20 TO 15 HOLES AND CONTOURED PRIOR TO IMPLANTATION; THE BREAK DID NOT OCCUR IN THE CONTOURED REGION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH REPETITIVE BENDS AS STATED IN THE COMPLAINT DESCRIPTION. AS PER TECHNIQUE GUIDE: AVOID REVERSE BENDS, REPETITIVE BENDS, AND SHARP BENDS. REVERSE, REPETITIVE, OR SHARP BENDS MAY WEAKEN THE PLATE AND LEAD TO PREMATURE PLATE FAILURE. 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

    PATIENT'S AGE PROVIDED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL NARRATIVE: PATIENT IDENTIFIER, DATE OF BIRTH/AGE, AND WEIGHT ARE UNKNOWN. (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MANDIBLE RECONSTRUCTION PROCEDURE ON (B)(6) 2016. DURING THE PROCEDURE, THE SURGEON WAS MANIPULATING A TITANIUM MATRIXMIDFACE PLATE IN ORDER TO SHAPE IT TO THE TEMPLATE. AFTER REPEATED BENDING, THE PLATE BROKE. A BACK-UP PLATE WAS READILY AVAILABLE, BUT A TWENTY (20) MINUTE DELAY RESULTED. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133995 TI MATRIXMANDIBLE 20 HOLE RECON PLATE 2.5MM THICK BONE PLATE JEY SYNTHES ELMIRA 9940504

    Patients

    Seq Age Sex Outcome Treatment
    1