BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM

    MDR report key: 6459392 · Received April 4, 2017

    Report

    Report Number
    9612488-2017-10152
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    March 9, 2017
    Report Date
    March 14, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: FEB 3, 2016. EXPIRATION DATE: JAN 1, 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT LOT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR NON-STERILE PART# 04.503.410.20, LOT# 9860490. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUL 20, 2015. (B)(4) MATERIAL PART NO: 21015, LOT 9830164 RECEIVED FROM SUPPLIER (B)(4). (B)(4) MATERIAL REWORK INSPECTION MEET SPECIFICATION. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: OUR INVESTIGATION SHOWS THAT SCREW WAS FOUND BROKEN AT SCREW'S SHAFT. THE BROKEN PART IS MISSING. FURTHERMORE THERE ARE MECHANICAL DAMAGES VISIBLE AT CRUCIFORM-RECESS. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION ISSUE. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AS NO DETAILED CLINICAL INFORMATION IS PROVIDED. AS INDICATED IN THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL WAS USED AND RAW MATERIAL CERTIFICATE MET SPECIFICATION. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE SHOWS A HOMOGENOUS SURFACE WHICH AT INDICATES MATERIAL CONFORMITY. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. DUE TO THE DAMAGE AND THE WEAR AND TEAR SIGNS, IT IS LIKELY THAT A MECHANICAL OVERLOAD SITUATION DURING USE LEAD TO THE COMPLAINED ISSUE. BASED ON THESE RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A MIDLINE MANDIBULOTOMY PROCEDURE ON (B)(6) 2017, THE MATRIX MANDIBLE SCREW BROKE DURING INSERTION. WHEN THE SURGEON WAS INSERTING THE REPORTED SCREW HE REPORTED THAT IT LOST PURCHASE DURING TIGHTENING AFTER TWO OR THREE TURNS. IT WAS THEN DISCOVERED THAT THE SCREW HEAD HAD DETACHED FROM THE SCREW SHAFT. THE OTHER THREE (3) SCREWS LOCKED TO THE PLATE WITHOUT ISSUE AND THE SCREW SHAFT OF THE BROKEN SCREW WAS RETAINED IN THE PATIENT. THE SURGERY WAS DELAYED FOR AN UNKNOWN DURATION OF TIME DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT HARM AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. CONCOMITANT DEVICES: 1X SCREWDRIVER (PART AND LOT UNKNOWN); 1X PLATE (PART AND LOT UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237930 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM PLATE, BONE JEY SYNTHES BETTLACH 9806739

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PLATE, QTY 1