BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X36MM

    MDR report key: 17648644 · Received August 30, 2023

    Report

    Report Number
    0009613350-2023-00498
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 4, 2023
    Report Date
    November 17, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505421
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2-FOREIGN-JAPAN. D10. ITEM#:47-2496-160-09 ;LOT#:3128403 ;ITEM NAME: PROXIMAL HUMERUS, RIGHT, 9X160MM. THE FOLLOWING SCREWS WERE IMPLANTED DURING THE INITIAL PROCEDURE, AND IT IS UNKNOWN WHICH SCREW EXACTLY HAD BACKED OUT:- ITEM#:47-2486-036-40 ;LOT#:3091452 ;ITEM NAME: BLUNT TIP SCREW, 4X36MM. ITEM#:47-2486-038-40 ;LOT#:3086931 ;ITEM NAME: BLUNT TIP SCREW, 4X38MM. ITEM#:47-2486-040-40 ;LOT#:3147804 ;ITEM NAME: BLUNT TIP SCREW, 4X40MM. ITEM#:47-2486-044-40 ;LOT#:3091413 ;ITEM NAME: BLUNT TIP SCREW, 4X44MM. ITEM#:47-2486-044-40 ;LOT#:3091415 ;ITEM NAME: BLUNT TIP SCREW, 4X44MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS: 0009613350-2023-00501. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, E1, G3, G6, H2, H3, H6 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. THE SURGICAL TECHNIQUE EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN ANDENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE NOT PROVIDED. IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT AS THIS ISSUE WAS ALREADY ADDRESSED IN A PREVIOUSLY CA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MEDWATCH: 0009613350-2023-00501. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE WEEKS POST-IMPLANTATION ONE OF THE SCREWS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315603 BLUNT TIP SCREW, 4X36MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURER GMBH 3091452 00889024505421

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.