BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAT LOCK L-PLATE W/POSITIONING HOLE SHOR

    MDR report key: 10928969 · Received December 1, 2020

    Report

    Report Number
    8030965-2020-09292
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 4, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819385481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: DAMAGED: VISUAL, EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: THE PLATE IS BROKEN APART AT THE TRAVERSE BETWEEN THE HOLES. THE PLATE WAS STRONGLY BENT IN DIFFERENT DIRECTION BEFORE IT BROKE. IN GENERAL, THE PLATE IS IN A VERY BAD CONDITION WITH EXTREME MARKS OF THE BENDING TOOL ALL OVER. ESPECIALLY IN THE AREA WHERE THE BREAKAGE OCCURRED, THERE ARE NUMEROUS DEEP MARKS PRESENT. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766: PLATE THICKNESS, SPECIFICATION / MEASURED: PASS, PLATE WIDTH, SPECIFICATION / MEASURED: DAMAGED, THE PLATE IS TOTALLY DEFORMED IN THIS AREA FORM THE DEEP IMPRESSION MARKS OF THE USED BENDING TOOL. DOCUMENT/SPECIFICATION REVIEW: THE MATRIX ORTHOGNATHIC LOCK INSTRUCTION FOR USE (EUCMF07018 SE_531341 AE 08/2017) WAS REVIEWED AND FOLLOWING STATEMENTS CAN BE POINTED OUT RELATED TO THIS COMPLAINT: THESE DEVICES CAN BREAK DURING USE (WHEN SUBJECTED TO EXCESSIVE FORCES OR OUTSIDE THE RECOMMENDED SURGICAL TECHNIQUE). DO NOT EXCESSIVELY BEND THE PLATES AS IT MAY PRODUCE INTERNAL STRESSES WHICH MAY BECOME THE FOCAL POINT FOR EVENTUAL BREAKAGE OF THE IMPLANT. INVESTIGATION CONCLUSION: THE COMPLAINT IS RATED AS CONFIRMED AS THE PLATE IS BROKEN AS COMPLAINED. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. BASED ON THE VERY BAD CONDITION IT CAN BE CONCLUDED THAT EXCESSIVE BACK AND FORTH BENDING IN COMBINATION WITH THE VERY DEEP IMPRESSION MARKS DID CAUSE THE BREAKAGE OF THIS DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT, PART: 04.511.900S, LOT: 4L29217, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 08 MAY 2019, EXPIRY DATE: 01 APRIL 2029. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE: MARCH 27, 2019. THE RAW MATERIAL CERTIFICATE 19701 WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO ISO-5832-2 SPECIFICATION. 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. CORRECTED DATA: H3, H6.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OSTEOTOMY ON THE MAXILLARY ALVEOLAR BONE ON (B)(6) 2020, WHEN THE SURGEON BENT THE PLATE FEW TIMES, IT BROKE OFF. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT'S OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MAT LOCK L-PLATE W/POSITIONING HOLE SHOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395916 MAT LOCK L-PLATE W/POSITIONING HOLE SHOR PLATE, FIXATION, BONE HRS SYNTHES GMBH 4L29217 07611819385481

    Patients

    Seq Age Sex Outcome Treatment
    1