BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5098738 · Received September 23, 2015

    Report

    Report Number
    2520274-2015-16098
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    September 7, 2015
    Report Date
    September 11, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EIGHT SCREWS WERE RECEIVED BY THE MANUFACTURER ON NOV 27, 2015. ONE, PART NUMBER 413.320S, LOT NUMBER 9428314, LOCKSCR Ø5 SELF-TAP L20 TAN, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). ONE, PART NUMBER 413.340S, LOT NUMBER 8796337, 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM--STERILE, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) K023941, (B)(4). TWO, PART NUMBER 413.346S, LOT NUMBER 8937849, 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 46MM¿STERILE, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) K000682, (B)(4). TWO, PART NUMBER 413.344S, LOT NUMBER 9251280, 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 44MM¿STERILE, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) K023941, (B)(4). ONE, PART NUMBER 413.334S, LOT NUMBER 9027933, 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 34MM¿STERILE, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) K000682, (B)(4). ONE, PART NUMBER 413.332S, LOT NUMBER 9073602, 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 32MM¿STERILE, DEVICE PRODUCT CODE¿KTT, COMMON NAME¿APPLIANCE, FIXATION, NAIL, 510(K) K000682, (B)(4). DEVICE HISTORY RECORD REVIEWS WERE PERFORMED FOR THE RECEIVED SCREWS. NO NON-CONFORMANCE REPORTS (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. OTHER RESULTS OF THE DEVICE HISTORY RECORD REVIEWS ARE AS FOLLOWS: 413.320S - 9428314: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 20.APR.2015, EXPIRY DATE: 01.APR.2025. 413.332S - 9073602: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 06.AUG.2014, EXPIRY DATE: 01.JUL.2024. 413.334S - 9027933: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 24.JUN.2014, EXPIRY DATE: 01.JUN.2024. 413.340S - 8796337: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 21.JAN.2014, EXPIRY DATE: 01.JAN.2024. 413.344S - 9251280: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 01.DEC.2014, EXPIRY DATE: 01.NOV.2024. 413.346S - 8937849: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 28.APR.2014, EXPIRY DATE: 01.APR.2024. THE SUBJECT DEVICE(S) HAVE BEEN RECEIVED AND ARE CURRENTLY IN THE EVALUATION PROCESS. THE SYNTHES MANUFACTURING LOCATION WAS IDENTIFIED UPON RECEIPT OF THE SUBJECT DEVICES. THE SUBJECT DEVICES WERE EXPLANTED ON AN UNKNOWN DATE. 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 INVESTIGATION SUMMARY ¿ THE BROKEN PLATE WAS RECEIVED AS DESCRIBED IN THE COMPLAINT DESCRIPTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. ON THE ORIGINAL MEASURING DATA AND ALL FEATURES ON THE INSPECTION SHEET ARE WITHIN SPECIFICATION. ON THE BROKEN TOMOFIXTIBIAHEAD PLATE ALL SIGNIFICANT FEATURES WERE MEASURED BY THE COORDINATE MEASURING MACHINE (CMM). ALL SIGNIFICANT FEATURES (I.E. PLATE THICKNESS, PLATE WIDTH, HOLE AND THREAD POSITIONS) WERE FOUND TO BE WITHIN SPECIFICATION. THREAD POSITION 1 AND 4 WERE NOT MEASUREABLE DUE TO THE DAMAGED THREADS. THE CAUSE FOR THE PLATE BREAKAGE IS NOT MANUFACTURING RELATED, IT IS ASSUMED THAT MECHANICAL OVERLOAD CAUSED THE DAMAGE/BREAKAGE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. NO PRODUCT PROBLEM IDENTIFIED. THERE WERE ALSO EIGHT (8) INTACT SCREWS RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED. AS NO COMPLAINT IS LEVIED ON THE SCREWS AND AS THE SCREWS INTACT, NO FURTHER INVESTIGATION WILL BE DONE. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: WE COULD NOT CONFIRM EXACTLY HOW THIS COMPLAINT OCCURRED, AS NO MATERIAL RECEIVED. NO FURTHER INFORMATION WAS AVAILABLE. PRODUCT WAS NOT RETURNED TO OUR LOCATION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE; HOWEVER, BECAUSE THIS DEVICE IS DWELLING IN THE AREA OF THE REPORTED EVENT IT CANNOT BE DISASSOCIATED FROM THE REPORTED ADVERSE EVENT. THE REPORTED EVENT MAY REQUIRE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. THIS REPORT IS FOR ONE UNKNOWN SCREW. PART AND LOT NUMBERS WERE NOT PROVIDED BY THE REPORTED. THE SUBJECT DEVICE MAY STILL REMAIN IMPLANTED IN THE PATIENT. (B)(4) UNANTICIPATED X-RAYS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IT WAS REPORTED THAT THE SUBJECT DEVICE WOULD NOT BE RETURNED FOR EVALUATION. 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

    X-RAY REVIEW CAN CONFIRM THE PLATE BREAKAGE.

    Description of Event or Problem · 1

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TOMOFIX PLATE (LEFT KNEE), INITIALLY IMPLANTED DURING A HIGH TIBIAL OSTEOTOMY OF BOTH KNEES AND ACL RECONSTRUCTION AT THE LEFT KNEE ON (B)(6) 2015, BROKE POST-OPERATIVELY CAUSING THE PATIENT PAIN. THE SURGEON REPORTED THAT THE PATIENT HAD UNDERGONE REHABILITATION AND THAT FULL WEIGHT BEARING STARTED ON (B)(6) 2015. THE SURGEON ALSO MENTIONED THE REHABILITATION PROGRAM HAD NOT YET INCLUDED TWISTING MOTIONS OF THE OPERATED AREAS. INFORMATION REGARDING PLANS FOR REVISION SURGERY OR OTHER TREATMENT WAS NOT REPORTED. THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627725 SCREW, FIXATION, BONE HWC SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention