MAUDE Adverse Event Report: PARCUS MEDICAL , L.L.C. ATLAS; ATLAS- DT W- GFS AND DRILL BIT

Model Number	11200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review: lot 19083: a total of (b)(4) parts were manufactured on 28 february 2024 and transferred into inventory on 25 april 2024.The product expiration date is 27 february 2029.No nonconformances were associated with the manufacturing or assembly of the product.A deviation was documented for the temporary use of blank white labels as tamper tape until a new shipment of approved tamper tape was received.This deviation had no impact on product material, quality, or functionality.The subcomponent subassembly and flipper button were both manufactured and assembled without any associated nonconformances or deviations.There are (b)(4) parts from this lot currently remaining in inventory.To date, no similar events have been reported for this lot.Clinical evaluation: a revision surgery was performed approximately one year after the cmc arthroplasty due to implant failure.The available x-ray images are undated; therefore, it is unclear whether they correspond to the time at which the surgeon declared the failure.The images do not demonstrate clear pathological subsidence of the first metacarpal bone, which appears only slightly lowered.The button also appears slightly offset from the bone (protruding proximally); however, this finding alone is insufficient to establish implant failure.Any such diagnosis should be correlated with clinical symptoms and supported by additional imaging.It should also be noted that the outcome of this type of procedure is highly dependent on postoperative management and patient compliance.Additional information regarding postoperative behavior and rehabilitation would therefore be valuable.Based on the currently available information, no definitive conclusions can be drawn.Investigation: root cause cannot be established at this time.(b)(4) parts have been sold with no other reports of this failure mode.This is the first time this failure mode has been reported for this part number.There were no manufacturing or assembly batch records for the finished good and its subcomponents that indicated a cause of failure.For a standard cmc repair procedure comparable to the one performed on the complainant, a patient following post-op instructions would have sufficient time for healing based on the original surgery date ((b)(6) 2025) and the time of the reported pain and swelling ((b)(6) 2025).A post-op time period of 10 months provides sufficient time for the affected area to heal and have bone growth.There is little information about the end user and their activites that may have contributed to the failure.Conclusion: based on batch review results showing no manufacturing or assembly nonconformances, no similar events reported for the lot, and the absence of definitive radiographic evidence of implant failure, the root cause of the reported event cannot be conclusively determined.The event is most likely related to clinical or postoperative factors, including patient-specific anatomy, surgical technique, or postoperative management, rather than a product-related defect.
Event or Problem Description
Primary surgery, performed on (b)(6) 2025, involved a cmc arthroplasty combined with mcp arthrodesis.The initial postoperative course was uneventful.However, starting in (b)(6) 2025, the patient reported swelling and pain at the base of the thumb.Radiographic investigations revealed collapse of the thumb metacarpal, consistent with a possible failure of the cmc reconstruction.Consequently, a revision surgery was scheduled and performed on (b)(6) 2025.

• Brand Name: ATLAS
• Common Device Name: ATLAS- DT W- GFS AND DRILL BIT
• Manufacturer (Section D): PARCUS MEDICAL , L.L.C.; 6423 parkland drive; sarasota; florida 34243
• Manufacturer (Section G): PARCUS MEDICAL , L.L.C.; 6423 parkland drive; sarasota 34243
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 24267168
• Report Number: 3007319107-2026-00001
• Device Sequence Number: 10726474
• Product Code: MBI
• UDI-Device Identifier: 00816342024983
• UDI-Public: 00816342024983
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11200
• Device Lot Number: 19083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female