BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER FOR 1.0MM, 1.3MM,1.5MM, 2.0MM PLATES

    MDR report key: 5057108 · Received September 4, 2015

    Report

    Report Number
    2520274-2015-15697
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Report Date
    August 24, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE HISTORY EVALUATION/REVIEW WAS ATTEMPTED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: SERVICE HISTORY REVIEW: PART NO: 391.98, NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    LOT NUMBER WAS IDENTIFIED UPON RECEIPT OF SUBJECT DEVICE AND ADDED. SERVICE/ MAINTENANCE REVIEW - EVAL ¿ THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE PLATE CUTTER BROKE. THE REPAIR TECHNICIAN REPORTED THE CUTTING INSERT BROKE OFF. CUTTING JAWS BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON 6-OCT-2015. THE EVALUATION WAS CONFIRMED. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE RETURNED PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES (391.98, T963956) IS USED IN CMF PROCEDURES AND INCLUDED IN THE ORTHODONTIC BONE ANCHOR (OBA), RAPIDSORB RAPID RESORBABLE FIXATION, 1.5MM MODULAR LCP, AND ALVEOLAR RIDGE DISTRACTOR SYSTEMS TO ASSIST IN THE MANIPULATION OF PLATES TO MEET SURGEON AND PATIENT NEEDS. THE RETURNED CUTTER WAS RECEIVED WITH SIGNS OF WEAR FROM ROUTINE USE IN ADDITION TO ONE OF ITS CUTTING BLADES BEING BROKEN AND SIGNS OF WEAR ON THE SECOND CUTTING BLADE AS WELL. THE COMPLAINT DESCRIPTION STATED THAT THE RETURNED CUTTERS BROKE WHILE BEING USED TO CUT A PLATE. IT IS NOT KNOWN WHAT TYPE OF PLATE WAS BEING CUT OR THE WAY IN WHICH THE CUTTERS WERE BEING USED. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE. IT IS POSSIBLE THAT THE SUSTAINED DAMAGE WAS A RESULT OF CUMULATIVE WEAR FROM HEAVY USAGE. ADDITIONALLY HANDLING OF THE CUTTERS IN AN UNINTENDED MANNER EITHER DURING SURGERY OR STERILE PROCESSING COULD HAVE ALSO CONTRIBUTED TO THE COMPLAINT CONDITION. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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

    (B)(6). 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE SERVICE AND REPAIR HISTORY RECORDS COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(4): A SECOND SERVICE HISTORY EVALUATION/REVIEW WAS ATTEMPTED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE SERVICE HISTORY REVIEW: PART NO: 391.98, LOT NO: T963956, NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 1-DEC-2011. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    IT WAS REPORTED THAT A PIECE OF THE PLATE CUTTER BROKE WHEN THE SURGEON WAS CUTTING A PLATE ON THE BACK TABLE DURING SURGERY. DATE OF SURGERY AND TYPE OF PROCEDURE IS UNKNOWN AND WILL NOT BE AVAILABLE. ANOTHER PART WAS IMMEDIATELY AVAILABLE, THERE WAS NO SURGICAL DELAY. NO FURTHER PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588746 PLATE CUTTER FOR 1.0MM, 1.3MM,1.5MM, 2.0MM PLATES INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ SYNTHES TUTTLINGEN T963956

    Patients

    Seq Age Sex Outcome Treatment
    1