BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIC-FORCEPS F/RAPIDSORB CRANIAL CLAMP

    MDR report key: 3494700 · Received December 2, 2013

    Report

    Report Number
    8030965-2013-05347
    Event Type
    Malfunction
    Date Received
    December 2, 2013
    Report Date
    November 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL COMMON DEVICE NAME HXZ. THE PRODUCT DEVELOPMENT EVALUATION REPORTED THE CUSTOMER STATES THAT THE INSTRUMENT WILL BE TREATED AS A SINGLE USE INSTRUMENT DUE TO THE LACK OF ABILITY TO CLEAN. HOWEVER, THE CLEAN INSTRUCTIONS ARE SHOWN BY SE_528721 AND THE STATE OF THE DEVICE IS NOT CONSISTENT WITH A SINGLE USE INSTRUMENT. THE RETURNED DEVICE IS WELL WORN AND SHOWS OBVIOUS SIGNS OF WEAR AND TEAR. THE COMPLAINED DEVICE IS APPROVED FOR CLEANING AND STERILIZATION. THE VISUAL INSPECTION PERFORMED AS PART OF THE ADDITIONAL EVALUATION INDICATED THE DEVICE APPEARS VERY WORN AND USED, CUSTOMER USED MARKING TAPE ON ONE HANDLE. FROM A CUSTOMER VIEW THIS INSTRUMENT IS NOT EASY TO CLEAN AND CHECK AFTERWARDS, BECAUSE THE CUTTING PART IS BUILDING A CAVE, WHICH CAN¿T BE FLUSHED EASILY. NEVERTHELESS THIS HAS BEEN REGARDED AS A COMPLEX DEVICE (ACCORDING TO THE DESIGN-FEATURES) AND SHOULD SHOW THE RECOMMENDED REDUCTION OF PROTEINS ¿ IF OUR ¿IMPORTANT INFORMATION¿ IS FOLLOWED EXACTLY ¿ SIMILAR TO OUR REFERENCE VALIDATIONS. THE COMPLAINT WAS DETERMINED TO BE INVALID. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: FACILITY REPORTS THAT THE CUTTING PART OF THE INSTRUMENT IS NOT PROVEN TO BE CLEAN AFTER ULTRASONIC WASHING. IT IS THE OPINION OF THE MEDICAL EXPERT FOR STERILITY, THIS INSTRUMENT CANNOT BE CLEANED ACCORDING TO REGULATIONS DUE TO THE CONSTRUCTION OF THE DEVICE NOT BEING DETACHABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623254 APPLIC-FORCEPS F/RAPIDSORB CRANIAL CLAMP HXQ SYNTHES GMBH A7PA46

    Patients

    Seq Age Sex Outcome Treatment
    1