BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SPREADER 12 MM BEAK WIDTH

    MDR report key: 3953513 · Received July 23, 2014

    Report

    Report Number
    2520274-2014-12740
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HWN
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE HANDLE SPRING IS BROKEN. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT FOR FURTHER INVESTIGATION. 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

    SERVICE HISTORY REVIEW: LOT 2022: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED.(B)(4).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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: OUR INVESTIGATION SHOWS WEAR AND TEAR SIGNS ON THE SURFACE. THE TIPS ARE SLIGHTLY WORN OUT AND THE FORCEPS IS MOVABLE. ONE FLAT SPRING IS BROKEN OFF AND THE SECOND ONE WAS DISASSEMBLED FROM THE FORCEPS. THE LASER ETCHING IS READABLE. ONLY THE ARTICLE NUMBER AND THE LOT NUMBER ARE SPECIFIED ON THE DEVICE. THE ARTICLE/ LOT NUMBER COMBINATION IS UNKNOWN AT SYNTHES (B)(4), THEREFORE, NO MANUFACTURING EVALUATION IS POSSIBLE. THE LASER ETCHING, ON DRAWING (B)(4) VERSION 00 RELEASED ON OCTOBER 2002, CONSISTS WITH THE SYNTHES LOGO, THE ARTICLE NUMBER, THE LOT NUMBER AND THE CE-MARKING. BASED ON THESE RESULTS IT IS LIKELY THAT THE DEVICE MUST BE OLDER THAN 20 YEARS BECAUSE ONLY THE ARTICLE NUMBER, THE LOT NUMBER AND THE MANUFACTURING SITE ((B)(4)) WERE ETCHED ON THE DEVICE. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT ROOT CAUSE, WHICH HAS LED TO THIS OCCURRENCE. IT IS LIKELY THAT THE DAMAGE WAS CAUSED DUE TO AN OFTEN AND EXCESSIVE USE IN COMBINATION WITH A MECHANICAL OVERLOAD SITUATION. THE COMPLAINT RELEVANT DIMENSIONS COULD NOT BE CHECKED DUE TO THE DAMAGE. THEREFORE THIS MANUFACTURING EVALUATION IS TO BE INVALID FROM A MANUFACTURING STANDPOINT. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS:IT WAS REPORTED THAT THE BONE SPREADER 12MM BEAK WIDTH HANDLE SPRING IS BROKEN. NO INCIDENT HAS BEEN REPORTED. THIS EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430288 BONE SPREADER 12 MM BEAK WIDTH INSTRUMENT COMPRESSION HWN SYNTHES SALZBURG 2022

    Patients

    Seq Age Sex Outcome Treatment
    1