BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 4791120 · Received May 22, 2015

    Report

    Report Number
    9612488-2015-10283
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 4, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). PATIENT WEIGHT IS UNKNOWN. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE US. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 10, 2009. NO NON-CONFORMANCE REPORTS 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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PREFORMED ¿ THE CONNECTING SCREW IS BROKEN IN HALF AT THE RUN OUT OF THE CONNECTION THREAD. THE FRACTURE FACE IS HOMOGENOUS, WHAT INDICATES MATERIAL CONFORMITY AND SHOWS THE TYPICAL VIEW OF A FORCED RUPTURE. THE GUIDING SHAFT ON THE TIP IS SLIGHTLY DEFORMED AND SHOWS ONE STRONG NICK BUT ALSO SOME MINOR NICKS FROM UNKNOWN SOURCE. THERE ARE ALSO STRIATIONS OF USE ON THE UPPER SHAFT. ALL MARKS AND STRIATIONS WERE CAUSED POST-MANUFACTURING. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE VALID TECHNICAL DRAWINGS. LOT 2468098 WAS MANUFACTURED IN JUNE 2009, (B)(4) PIECES ACCORDING TO OUR SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD HAVE CAUSED THE COMPLAINT CONDITION. THE DHR REVIEW SHOWS THAT CORRECT MANUFACTURING PROCESS AND HARDENING PROCEDURES WERE USED. WE ARE NOT AWARE OF ANY OTHER BREAKAGES OF THE CONCERNED ARTICLE/LOT NUMBER. NO PRODUCT RELATED CONDITION WAS DETECTED. WE SUPPOSE THAT A MECHANICAL OVERLOADING SITUATION CAUSED THE BREAKAGE. 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 A CONNECTING SCREW BROKE DURING AN OPERATION ON (B)(6) 2015. ANOTHER SCREW WAS AVAILABLE TO CONNECT THE JIG AND THE NAIL FOR INSERTING INTO THE PATIENT¿S BODY. A NINETY (90) MINUTE DELAY WAS NOTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336550 CONNECSCR F/CFN/AFN F/SYNREAM SCREW, FIXATION, BONE HWC SYNTHES BETTLACH 2468098

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention