BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOFIXTIBHEADPL ANATOM MED PROX R HE 4H

    MDR report key: 10556885 · Received September 18, 2020

    Report

    Report Number
    8030965-2020-07231
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    January 1, 2020
    Report Date
    August 24, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07612334080257
    Adverse Event
    Yes
    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. VISUAL INSPECTION: THE PLATE WAS FOUND BROKEN AT THE 5TH HOLE, COUNTED FROM THE END SIDE. THE BREAKAGE POINT GOES THROUGH THE THREADED HOLE. MOREOVER, THERE ARE SLIGHTLY SIGNS OF USE VISIBLE ON THE ENTIRE SURFACE. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION WAS PERFORMED AS BELOW: FEATURE: PLATE THICKNESS (LONGER BROKEN PART) DRAWING: CALIPER: 3-01-17582 DIMENSION DRAWING: DIMENSION MEASURED: RESULT: PASS. FEATURE: PLATE THICKNESS (SHORTER BROKEN PART) DRAWING: CALIPER: 3-01-17582 DIMENSION DRAWING: DIMENSION MEASURED: RESULT: PASS. FEATURE: PLATE WIDTH (LONGER BROKEN PART) DRAWING: CALIPER: 3-01-17582 DIMENSION DRAWING: DIMENSION MEASURED: RESULT: PASS. FEATURE: PLATE WIDTH (SHORTER BROKEN PART) DRAWING: CALIPER: 3-01-17582 DIMENSION DRAWING: DIMENSION MEASURED: RESULT: PASS. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH THE INTERNATIONAL STANDARD ISO 5832-2 FOR IMPLANTS FOR SURGERY. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS THE PLATE WAS FOUND BROKEN. THIS LOT WAS MANUFACTURED IN NOVEMBER 2019 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION. THIS AND THE FINDINGS ABOVE LET US EXCLUDE A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, MAL-UNION, OVERLOADING OF THE OSTEOSYNTHESIS OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 DEVICE HISTORY LOT PART: 440.838S , LOT: 26P1742, MANUFACTURING SITE: RARON, RELEASE TO WAREHOUSE: NOV 28, 2019 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE LOT NUMBER OF THE FINISHED DEVICE. A DEVIATION REPORT WAS IDENTIFIED AT THE SUPPLIER (B)(4).THE NON-CONFORMITY REPORT WAS OF THE TYPE "OVERDELIVERY" AND WAS DETECTED DURING THE INCOMING INSPECTION. THE NON-CONFORMITY OF THE SUPPLIER "FRÜH VERPACKUNGSTECHNIK AG" HAS NO INFLUENCE ON THE QUALITY OF THE DEVICES. 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

    EVENT YEAR IS REPORTED AS 2020; HOWEVER EXACT DATE OF EVENT IS UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, ALL THE IMPLANTS WERE REMOVED AND THE PTP LARGE PLATE (4 HOLES) WAS LATERALLY IMPLANTED IN ADDITION TO THE TOMOFIX (ANATOMICAL) PLATE. ORIGINALLY, THE PATIENT HAD HTO (HYBRID CLOSED WEDGE) SURGERY FOR TIBIAL FRACTURES BY USING THE TOMOFIX (ANATOMICAL) PLATE ON (B)(6) 2020. ON (B)(6) 2020, IT WAS CONFIRMED IN AN X-RAY THAT THE PLATE HAD BEEN BROKEN. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: LOCKING SCREW (PART#: 413.320S, LOT#: 9823275, QUANTITY: 1); LOCKING SCREW (PART#: 413.338S, LOT#: 24P7934, QUANTITY: 1); LOCKING SCREW (PART#: 413.344S, LOT#: L833035, QUANTITY: 1); LOCKING SCREW (PART#: 413.355S, LOT#: 4L00553, QUANTITY: 1); LOCKING SCREW (PART#: 413.360S, LOT#: L810757, QUANTITY: 1); LOCKING SCREW (PART#: 413.370S, LOT#: 5L94554, QUANTITY: 1); LOCKING SCREW (PART#: 413.370S, LOT#: 46P1835, QUANTITY: 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TOMOFIXTIBHEADPL ANATOMY MED PROX R HE 4H THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017354 TOMOFIXTIBHEADPL ANATOM MED PROX R HE 4H PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 26P1742 07612334080257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKSCR Ø5 SELF-TAP L20 TAN| LOCKSCR Ø5 SELF-TAP L38 TAN| LOCKSCR Ø5 SELF-TAP L44 TAN| LOCKSCR Ø5 SELF-TAP L55 TAN| LOCKSCR Ø5 SELF-TAP L60 TAN| LOCKSCR Ø5 SELF-TAP L70 TAN