BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    MDR report key: 6376978 · Received March 3, 2017

    Report

    Report Number
    1719045-2017-10175
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 8, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    UDI-DI
    07611819908543
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE IMPLANT DATE OF (B)(6) 2017 WAS REPORTED IN ERROR IN THE INITIAL MEDWATCH (B)(4). STATE (B)(6) WAS ENTERED IN ERROR IN INITIAL MEDWATCH (B)(4) 510(K): IS K083388. PATIENT CODE (B)(4), REPORTED IN ERROR IN INITIAL MEDWATCH #(B)(4), IS NOT APPLICABLE TO REPORTED EVENT AS SCREW FRAGMENT IS IMPLANT GRADE MATERIAL AND PROLONGATION OF SURGERY DID NOT REPORTEDLY RESULT IN PATIENT HARM. 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 FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, DOB & WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. BRAND NAME/PART LISTED AS SCR Ø1.5 SELF-DRILL L5 TAN 1U I/CLIP. NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTED CONCOMITANT DEVICES: MATRIXMIDFACE SCREW (PART: 04.503.225.01C, LOT: H234048, QUANTITY: 11), MATRIXMIDFACE SCREW (PART: 04.503.224.01C, LOT: H246257, QUANTITY: 2), MATRIXMIDFACE SCREW (PART: 04.503.226.01C, LOT: H159317, QUANTITY: 4), MATRIXMIDFACE EMERGENCY SCREW (PART: 04.503.234.01C, LOT: 7474208, QUANTITY: 1), MATRIXMIDFACE ADAPTION PLATE (PART: 04.503.346, LOT: H039765, QUANTITY: 2). REPORTERS PHONE NUMBER: (B)(6). 510K#UNKNOWN, HOWEVER, K083388 WAS LISTED IN REPORT. THE SURGERY WAS PROLONGED BY 40 MINUTES DUE TO THE SCREW BODIES THAT REMAINED IN THE PATIENT. PER FS932 REV 6, THIS EVENT IS REPORTABLE AS A MALFUNCTION DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: 11-NOV-2016 PART #: 04.503.225.01C, LOT#: H234048 (NON-STERILE) - TI MATRIXMIDFACE SCREW SELF-DRILLING 5 MM. QUANTITIES 120. INSPECTION SHEET FOR INSPECT DIMENSIONAL FINAL INSPECTION - NS032748 REV: W MEET ACCEPTANCE CRITERIA OF INSPECTION SHEET. COMPONENTS: RAW MATERIAL LOT NO: 9954218 REVIEWED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017 THE SURGEON REDUCED A FRACTURE IN THE AREA OF THE MIDDLE THIRD OF THE PATIENT FACE AND PLACED A FIRST SELF-DRILLING MATRIXMIDFACE SCREW. WHEN HE ADJUSTED THE HEAD OF THE SCREW, IT BROKE INTRA-OPERATIVELY AND THE BODY OF THE SCREW REMAINED INTO THE PATIENT¿S BODY. THE SURGEON INSISTED ON PLACING A SECOND SCREW OF THE SAME DIMENSION AND EXPERIENCED THE SAME ISSUE. HE TRIED TO REMOVE THE BROKEN SCREWS, BUT WAS UNSUCCESSFUL SO THE SCREW BODIES REMAINED IN THE PATIENT. THE SURGERY WAS PROLONGED BY 40 MINUTES. THE PATIENT WAS STABLE. THE COMPLAINT INVOLVES 2 PARTS.. REPORTED CONCOMITANT DEVICES: MATRIXMIDFACE SCREW (PART: 04.503.225.01C, LOT: H234048, QUANTITY: 11), MATRIXMIDFACE SCREW (PART: 04.503.224.01C, LOT: H246257, QUANTITY: 2), MATRIXMIDFACE SCREW (PART: 04.503.226.01C, LOT: H159317, QUANTITY: 4), MATRIXMIDFACE EMERGENCY SCREW (PART: 04.503.234.01C, LOT: 7474208, QUANTITY: 1), MATRIXMIDFACE ADAPTION PLATE (PART: 04.503.346, LOT: H039765, QUANTITY: 2). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159112 TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM BONE PLATE JEY SYNTHES MONUMENT H234048 07611819908543

    Patients

    Seq Age Sex Outcome Treatment
    1 PART: 04.503.224.01C| PART: 04.503.225.01C| PART: 04.503.226.01C| PART: 04.503.234.01C| PART: 04.503.346