BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB HIP

    MDR report key: 7577032 · Received June 7, 2018

    Report

    Report Number
    8043933-2018-00016
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 8, 2018
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    PMA / PMN Number
    K122011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A FAILURE OF THE BRAINLAB DEVICE HAS OCCURRED, WHICH REQUIRED SURGICAL INTERVENTION TO PRECLUDE SERIOUS INJURY (UNSUCCESSFUL PLACEMENT OF IMPLANT), ALTHOUGH: ACCORDING TO THE HOSPITAL, THERE WAS NO NEGATIVE CLINICAL EFFECT FOR THIS SPECIFIC PATIENT DUE TO THIS ISSUE, NO (FURTHER) REMEDIAL ACTIONS WERE NECESSARY / PLANNED / DONE (BESIDES REMOVAL OF THE BROKEN THREAD PIECE), THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE IMPLANT WAS PLACED AS INTENDED. IT HAS BEEN DETECTED THAT SPECIFIC LOT NUMBERS OF THE BRAINLAB INSERT FOR CUP IMPACTOR UNIVERSAL (CORIN) WERE POTENTIALLY MANUFACTURED ACCORDING TO INCORRECT SPECIFICATIONS PROVIDED BY BRAINLAB TO THE CORRESPONDING SUPPLIER. AS A RESULT, THE INSERT'S THREADED TIP MAY NOT BE ABLE TO WITHSTAND THE FORCES APPLIED DURING SURGERY AND BREAKAGE MAY OCCUR. DESPITE THE BREAKAGE IS SUCH THAT THE BROKEN THREAD PIECE IS EXPECTED TO BE LARGE ENOUGH TO BE GRABBED BY E.G. FORCEPS AND THUS COULD BE REMOVED, ITS REMOVAL IS CONSIDERED A SURGICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY (UNSUCCESSFUL PLACEMENT OF IMPLANT). ELEVEN SPECIFIC ITEMS OF THE BRAINLAB INSERT FOR CUP IMPACTOR UNIVERSAL (CORIN) ARE POTENTIALLY AFFECTED, 10 OF WHICH WERE ON STOCK AND ARE BLOCKED AS NONCONFORMING. ONE ITEM WAS DISTRIBUTED TO 1 CUSTOMER IN (B)(6) (THIS CUSTOMER). BRAINLAB INTENDS TO: INFORM THIS HOSPITAL ABOUT THE INVESTIGATION RESULTS. PROVIDE A REPLACEMENT HARDWARE TO THIS CUSTOMER TO CORRECT FOR THIS POTENTIAL ERROR. CORRECT THE RELEVANT PRODUCT SPECIFICATIONS AND PERFORM STOCK RECOVERY.

    Description of Event or Problem · 1

    IN THIS SPECIFIC CASE ON (B)(6) 2018 IN A HOSPITAL IN (B)(6), A HIP SURGERY HAS BEEN PERFORMED, WHEREBY THE CUP IMPLANT WAS PLACED WITH THE AID OF THE BRAINLAB CUP IMPACTOR UNIVERSAL STRAIGHT, IN COMBINATION WITH THE BRAINLAB INSERT FOR CUP IMPACTOR UNIVERSAL (CORIN). DURING IMPACTION THE INSERT'S THREADED TIP BROKE. THE SURGEON WAS ABLE TO REMOVE THE PROJECTING THREAD PIECE FROM THE ALREADY IMPLANTED CUP. EXCHANGEABLE INSERTS CAN BE USED FOR ADAPTATION OF THE BRAINLAB CUP IMPACTOR UNIVERSAL STRAIGHT TO BE USED WITH SPECIFIC CUPS. IT HAS BEEN DETECTED THAT SPECIFIC LOT NUMBERS OF THE BRAINLAB INSERT FOR CUP IMPACTOR UNIVERSAL (CORIN) WERE POTENTIALLY MANUFACTURED ACCORDING TO INCORRECT SPECIFICATIONS PROVIDED BY BRAINLAB TO THE CORRESPONDING SUPPLIER. AS A RESULT, THE INSERT'S THREADED TIP MAY NOT BE ABLE TO WITHSTAND THE FORCES APPLIED DURING SURGERY AND BREAKAGE MAY OCCUR. DESPITE THE BREAKAGE IS SUCH THAT THE BROKEN THREAD PIECE IS EXPECTED TO BE LARGE ENOUGH TO BE GRABBED BY E.G. FORCEPS AND THUS COULD BE REMOVED, ITS REMOVAL IS CONSIDERED A SURGICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY (UNSUCCESSFUL PLACEMENT OF IMPLANT). ACCORDING TO THE HOSPITAL, THERE WAS NO NEGATIVE CLINICAL EFFECT FOR THIS SPECIFIC PATIENT DUE TO THIS ISSUE, NO (FURTHER) REMEDIAL ACTIONS WERE NECESSARY / PLANNED / DONE (BESIDES REMOVAL OF THE BROKEN THREAD PIECE), THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE IMPLANT WAS PLACED AS INTENDED. ELEVEN SPECIFIC ITEMS OF THE BRAINLAB INSERT FOR CUP IMPACTOR UNIVERSAL (CORIN) ARE POTENTIALLY AFFECTED, 10 OF WHICH WERE ON STOCK AND ARE BLOCKED AS NONCONFORMING. ONE ITEM WAS DISTRIBUTED TO 1 CUSTOMER IN (B)(6) (THIS CUSTOMER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419417 BRAINLAB HIP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BRAINLAB AG 52855-41 7966116001, 7966116002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention