BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CURVED RECONSTRUCTION PLATE 10 HOLES/118MM

    MDR report key: 6791239 · Received August 14, 2017

    Report

    Report Number
    3006126083-2017-10031
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 18, 2017
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    UDI-DI
    07611819219755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. IMPLANT AND EXPLANT DATES: 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. PMA (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART: 445.320 / LOT: 9070006: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24 JULY 2014: NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    CUSTOMER QUALITY COMPLETED AN INVESTIGATION OF THE RETURNED DEVICE. RECEIVED CONDITION: THE PELVIC RECO-PLATE 3.5 CURV 10HO L118 TI IS BROKEN IN HALF AT THE EIGHT SCREW BORE. THE BROKEN OFF PORTION IS AVAILABLE FOR INVESTIGATION. THE PLATE WAS BENT FROM THIRD PARTY IN VARIOUS DIRECTIONS AND SHOWS MARKS AND NICKS IN DIFFERENT AREAS CAUSED FROM UNKNOWN INSTRUMENTS DURING PRE-BENDING. DIMENSION: THE RELEVANT DIMENSIONS WERE MEASURED IN UNDAMAGED AREA AND MEET FULLY TO THE SPECIFICATION. REVERENCED DIMENSIONS ON VALID TECHNICAL DRAWING: TARGET WIDTH OF PLATE: 10.00 +0.1 MM /- 0.3 MM. ACTUAL WIDTH OF HOOK MEASURED 9.85 MM / PASS. TARGET THICKNESS OF PLATE: 3.67 +/- 0.5 MM. ACTUAL THICKNESS OF PLATE MEASURED 3.60 MM / PASS. TARGET WIDTH OF SCREW HOLE: 4.8 +/- 0.2 MM. ACTUAL WITH OF SCREW HOLE MEASURED 4.76 MM / PASS. MATERIAL AND DHR REVIEW: THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD OF TI-CP PER ISO (B)(4). THE DEVICES MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. WE ARE NOT AWARE OF ANY QUALITY ISSUES ASSOCIATED WITH THIS ARTICLE- AND LOT NUMBER. CONCLUSION: THE PLATE SHOWS MARKS AND NICKS IN VARIOUS AREAS OF THE PLATE CAUSED FROM UNKNOWN INSTRUMENTS DURING PRE-BENDING. THE PLATE WAS BENT FROM THIRD PARTY IN VARIOUS DIRECTIONS. PLEASE TAKE NOTICE OF POINT 3 IN THE LEAFLET ¿IMPORTANT INFORMATION¿: ¿CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. IF THE SHAPE OF THE IMPLANT MUST BE ALTERED, THE DEVICE SHOULD NOT BE BENT SHARPLY, BENT BACKWARDS, NOTCHED, OR SCRATCHED. SUCH MANIPULATIONS, IN ADDITION TO ALL OTHER IMPROPER HANDLING OR USE, CAN PRODUCE SURFACE DEFECTS AND/OR CONCENTRATE STRESS IN THE CORE OF THE IMPLANT. THIS IN TURN MAY EVENTUALLY CAUSE THE PRODUCT TO FAIL.¿ THE PLATE SHOWS MARKS AND NICKS IN VARIOUS AREAS OF THE PLATE CAUSED FROM UNKNOWN INSTRUMENTS DURING PRE-BENDING. THE PLATE WAS BENT FROM THIRD PARTY IN VARIOUS DIRECTIONS. WE DETERMINE THE BREAKAGE TO BE CAUSED DURING A MECHANICAL OVERLOADING SITUATION. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE 3.5MM CURVED RECONSTRUCTION PLATE BROKE DURING SURGERY ON (B)(6) 2017. ANOTHER PLATE WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORT ON PATIENT'S INJURY. PATIENT OUTCOME REPORTED AS GOOD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF A SURGICAL PROLONGATION OCCURRED. UNKNOWN IF FRAGMENTS WERE GENERATED. UNKNOWN IF ANY OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR ONE (1) 3.5MM CURVED RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571730 3.5MM TI CURVED RECONSTRUCTION PLATE 10 HOLES/118MM PLATE,FIXATION,BONE HRS SYNTHES RARON 9070006 07611819219755

    Patients

    Seq Age Sex Outcome Treatment
    1