MAUDE Adverse Event Report: ARTHREX, INC. 36+6 / 39 COMBINATION HUMERAL INSERT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	36+6 / 39 COMBINATION HUMERAL INSERT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-9502f-36cpc univers revers suture cup, 36 (neutral) and an ar-9503-3639-6 36+6 / 39 combination humeral insert failed to lock into place properly.The surgeon attempted to insert the combination liner into the suture cup, but it would not engage securely.As no additional 36+6/39 combination liner was available in the implant bin, the surgeon had to remove the already placed implant, re-ream the glenoid to a size 39, and switch to alternative implants.This issue resulted in a 25-minute delay to the procedure.This was discovered during an rtsa procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 07/01/2025: the original implant liner failed to seat properly.Although it was partially engaged, it could not be fully inserted.While attempting to remove the liner, the surgeon used an osteotome and inadvertently broke the liner into two pieces.All fragments were successfully retrieved from the patient.Instead, alternative implant part numbers ar-9502f-39cpc and ar-9503m-06 were used to complete the case.The bone socket was prepared using a suturecup reamer on the humeral head.The patient¿s bone quality was assessed as normal.Due to the malfunction, an additional 25 minutes of anesthesia were administered.No adverse effects were reported during or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or mishandling.

• Brand Name: 36+6 / 39 COMBINATION HUMERAL INSERT
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 22518736
• Report Number: 1220246-2025-02897
• Device Sequence Number: 9231887
• Product Code: PHX
• UDI-Device Identifier: 00888867308879
• UDI-Public: (01)00888867308879(11)240801(17)290731(10)24.01894
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K191960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 36+6 / 39 COMBINATION HUMERAL INSERT
• Device Catalogue Number: AR-9503-3639-6
• Device Lot Number: 24.01894
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown