MAUDE Adverse Event Report: ARTHREX, INC. ARTHREXVIP WEB PORTAL; SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM

Model Number	ARTHREXVIP WEB PORTAL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a unvers reverse shoulder arthroplasty the surgeon discovered a discrepancy between the pdf hand-out and the web-based vip planning software.He noticed that he had planned a 100% backside seating and when he opened the pdf during the surgery, he realized that there was something different.He discovered that the stem was different, the screw lengths were missing and the marking for the augmented baseplate had disappeared.At this time, the patient was already under anesthesia.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully by using the web-based planning on the side.There was also no delay in the surgery time.

• Brand Name: ARTHREXVIP WEB PORTAL
• Common Device Name: SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 25731659
• Report Number: 1220246-2026-03626
• Device Sequence Number: 18762909
• Product Code: QHE
• UDI-Device Identifier: 00888867264953
• UDI-Public: 00888867264953
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K241097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARTHREXVIP WEB PORTAL
• Device Catalogue Number: 5566VIP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown