BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERUS, LEFT, 9X160MM

    MDR report key: 11899803 · Received May 28, 2021

    Report

    Report Number
    0009613350-2021-00239
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505810
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    D10: MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010655; ANN BLUNT TIP SCREW 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3010633; ANN BLUNT TIP SCREW 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3024673; ANN CORT BONE SCREW 4 X 30MM; CATALOG#: 47-2486-130-40; LOT#: 3024380; ANN CORT BONE SCREW 4 X 30MM; CATALOG#: 47-2486-130-40; LOT#: 3024382; AFFIXUS PH NL CAP 0MM; CATALOG#: 47-2488-010-00; LOT#: 3010702. THERAPY DATE: UNKNOWN. REVIEW EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON MAR 13, 2021 AND AFTER 1 MONTH THE SURGEON FOUND THAT 2ND SCREW WAS MIGRATED FROM THE PROPER POSITION. THE CORELOCK MECHANISM WAS ENGAGED WITH THE TORQUE DRIVER AFTER ALL THE INTERLOCKING SCREWS WERE PLACED. ADDITIONALLY, A NON-TORQUE DRIVER WAS USED FOR FURTHER TIGHTENING. NO REVISION SURGERY HAS BEEN PLANNED AS OF (B)(6) 2021. REVIEW OF RECEIVED DATA: DUE DILIGENCE: FURTHER "DUE DILIGENCE" TO SUPPORT THE CONCLUSION WAS COMPLETED. X-RAYS: ONE UNDATED AP X-RAY OF THE HUMERUS (WITHOUT ANY ANNOTATIONS ON THE X-RAY, SUCH AS WHICH SIDE) HAS BEEN RECEIVED. THE SECOND MOST PROXIMAL SCREW IS CONFIRMED TO HAVE MIGRATED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT. SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE 197-GLBL-EN EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." CONCLUSION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON MAR 13, 2021 AND AFTER 1 MONTH THE SURGEON FOUND THAT 2ND SCREW WAS MIGRATED FROM THE PROPER POSITION. THE CORELOCK MECHANISM WAS ENGAGED WITH THE TORQUE DRIVER AFTER ALL THE INTERLOCKING SCREWS WERE PLACED. ADDITIONALLY, A NON-TORQUE DRIVER WAS USED FOR FURTHER TIGHTENING. NO REVISION SURGERY HAS BEEN PLANNED AS OF (B)(6) 2021. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE RECEIVED X-RAY CONFIRM THE REPORTED EVENT, NAMELY THAT THE SECOND MOST PROXIMAL SCREW HAS MIGRATED. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION AND BEHAVIOUR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. IT WAS REPORTED, THAT THE LOCKING OF THE CORELOCK DURING IMPLANTATION HAS NOT BEEN PERFORMED AS SPECIFIED IN THE SURGICAL TECHNIQUE USING ONLY THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. INSTEAD, ADDITIONALLY A NON-TORQUE LIMITING SCREWDRIVER WAS USED. IT REMAINS UNKNOWN WHAT THE POTENTIAL EFFECT OF THIS DEVIATION FROM THE SURGICAL TECHNIQUE COULD BE AND HOW THIS MAY HAVE POTENTIALLY CONTRIBUTED TO THE SCREW MIGRATION. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED FOR THE TIME BEING AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010655, ANN BLUNT TIP SCREW 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3010633, ANN BLUNT TIP SCREW 4X38MM; CATALOG#: 47-2486-038-40; LOT#: 3024673, ANN BLUNT TIP SCREW 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010655, ANN CORT BONE SCREW 4 X 30MM; CATALOG#: 47-2486-130-40; LOT#: 3024380, ANN CORT BONE SCREW 4 X 30MM; CATALOG#: 47-2486-130-40; LOT#: 3024382, AFFIXUS PH NL CAP 0MM; CATALOG#: 47-2488-010-00; LOT#: 3010702. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. A MONTH POST IMPLANTATION IT WAS FOUND THAT 2ND SCREW HAD MIGRATED FROM ITS PROPER POSITION. A REVISION SURGERY HAS NOT YET TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801626 PROXIMAL HUMERUS, LEFT, 9X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3049723 00889024505810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization