BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 2X2H DCP PL 1.25MM THICK

    MDR report key: 5831829 · Received July 28, 2016

    Report

    Report Number
    3000270450-2016-10182
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    July 7, 2016
    Report Date
    July 11, 2016
    Manufacturer
    SYNTHES SELZACH
    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 USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 04.503.710S / 9601540 MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13TH AUGUST 2015, EXPIRY DATE: 1ST AUGUST 2025, ARTICLE WAS STERILIZED BY SUPPLIER (B)(4). ARTICLE 04.503.710 WAS MANUFACTURED IN THE US WITH LOT NUMBER 9861329. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24-JUL-2015, PART #: 04.503.710, LOT#: 9861329 (NON-STERILE) - TI MATRIX MANDIBLE 2X2 DCP PLATE 1.25MM THICK. 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. THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION DATE SUBJECT DEVICE WAS RECEIVED BY MANUFACTURER FOR EVALUATION. (B)(4). THE SUBJECT DEVICE IS CURRENTLY IN THE EVALUATION PROCESS. INITIAL MEDWATCH REPORT #(B)(4) INCORRECTLY STATED THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED BUT IT WAS. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE SUBJECT DEVICE WAS RECEIVED BY MANUFACTURER FOR EVALUATION. 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 INVESTIGATION EVALUATION: THE RETURNED DEVICE WAS RECEIVED LOOSE IN A BAG AND IS LASER ETCHED WITH PART 04.503.710 / LOT 9861329 (THE COMPLAINT IS ACTUALLY AGAINST THE STERILIZED PART WITH LOT 9601540). A VISUAL INSPECTION OF THE PLATE SHOWS THE PART IS TWISTED/BENT/DEFORMED WITH MARKS AND SCRATCHES PRESENT ON THE TOP AND BOTTOM SURFACES OF THE PLATE. THE FOLLOWING DETAILS WERE INSPECTED AND ALL FOUND TO BE CONFORMING: RAW MATERIAL, LENGTH, BEAM THICKNESS, SCALLOP THICKNESS, OVERALL THICKNESS, TOP BALL HOLE DEPTH, SLOT LENGTH (GO), SLOT LENGTH (NO GO), BOTTOM TROCAR DEPTH (ONLY HOLE 3 IS DEFORMED/TWISTED AND SCRATCHED/GOUGED), RADIAL THICKNESS, BOTTOM TROCAR WIDTH (ONLY HOLE 3 IS DEFORMED/TWISTED), THREAD DEPTH (ONLY HOLE 3 IS DEFORMED/TWISTED), MINOR DIAMETER DEPTH, BEAM WIDTH, OVERALL WIDTH, AND CONCENTRICITY. CONCLUSION: THIS LOG MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE FOR SHIPMENT WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IT HAS BEEN CONCLUDED ANY DAMAGE, TWISTING, OR OUT OF SPECIFICATION CONDITIONS IS DUE TO DAMAGE INCURRED AFTER THE PRODUCT LEFT MANUFACTURING FACILITY. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR MANDIBULAR FRACTURE ON (B)(6) 2016., THE SURGEON TRIED TO FIX THE REPORTED PLATE USING LOCKING SCREW (2.0 MM) AFTER BENDING THE PLATE. HOWEVER, A LOCKING SCREW PENETRATED A PLATE HOLE OF THE REPORTED PLATE. BEFORE THE PENETRATING, TWO LOCKING SCREWS WERE SUCCESSFULLY LOCKED IN THE OTHER PLATE HOLES OF THE PLATE. THE SURGEON DECIDED TO APPLY TITANIUM MATRIX MANDIBLE MINI PLATE TENSION BAND (1.0MM 4-HOLES), INSTEAD. THE SURGEON USED THE LOCKING SCREW TO PENETRATE THE REPORTED PLATE TO FIX PLATE TENSION BAND; THE SCREW WAS ABLE TO BE LOCKED IN PLATE HOLE OF THE TENSION BAND. AS THE SCREW WAS SUCCESSFULLY LOCKED IN THE HOLE, THE SURGEON THOUGHT THE REPORTED PLATE HAD THE CAUSE OF THE PENETRATION, SO HE DID NOT USE THE PLATE FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS REPORTED.. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484763 TI MATRIXMANDIBLE 2X2H DCP PL 1.25MM THICK BONE PLATE JEY SYNTHES SELZACH 9601540

    Patients

    Seq Age Sex Outcome Treatment
    1