BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, LEFT, 7X160MM

    MDR report key: 12275257 · Received August 4, 2021

    Report

    Report Number
    0009613350-2021-00386
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 24, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505803
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2020 AND AFTER TWO MONTHS FROM THE INITIAL SURGERY, #1 BLUNT SCREW HAD GRADUALLY MIGRATED 2CM FROM THE PROPER POSITION. THE REVISION SURGERY IS YET TO OCCUR. REVIEW OF RECEIVED DATA: DUE DILIGENCE: FURTHER DUE DILIGENCE TO SUPPORT THE CONCLUSION WAS COMPLETED AND DOCUMENTED IN DILIGENCE LOG. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS 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. NCR(S): NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. RAW MATERIAL CERTIFICATE: THE RAW MATERIAL CERTIFICATE WAS REVIEWED WITH NO ANOMALIES NOTED. SURGICAL TECHNIQUE SAP: 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 (B)(6) 2020 AND AFTER TWO MONTHS FROM THE INITIAL SURGERY, #1 BLUNT SCREW HAD GRADUALLY MIGRATED 2CM FROM THE PROPER POSITION. THE REVISION SURGERY IS YET TO OCCUR. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY HAVE AFFECTED THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE LOCKING OF THE CORELOCK DURING THE INITIAL SURGERY 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. BASED ON THE INVESTIGATION THE REPORTED EVENT CANNOT BE CONFIRMED. 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). 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, BEHAVIOR, 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. 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 EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X40MM; CATALOG#47-2486-040-40; LOT#3010638; BLUNT TIP SCREW, 4X36MM; CATALOG#: 47-2486-036-40; LOT#: 3024660; BLUNT TIP SCREW, 4X42MM; CATALOG#: 47-2486-042-40; LOT#: 3010651; CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 3039388; CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47-2486-126-40; LOT#: 3010596; PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47-2488-010-00; LOT#: 3046108. THERAPY DATE: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS OR OTHER SOURCE DOCUMENTS 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 AND TWO MONTHS FROM THE INITIAL SURGERY IT WAS REPORTED THAT THE FIRST BLUNT SCREW HAD GRADUALLY MIGRATED 2CM FROM THE PROPER POSITION. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FOLLOWED BY NON-TORQUE DRIVER TO TIGHTEN IT MORE. A REVISION SURGERY HAS NOT YET TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175060 PROXIMAL HUMERUS, LEFT, 7X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3049763 00889024505803

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization