MAUDE Adverse Event Report: ARTHREX, INC. REVERS 42MM CA ADAPTER ASSEMBLY; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	REVERS 42MM CA ADAPTER ASSEMBLY
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/9/2024, it was reported by a sales representative via email that an ar-9502-42arca univers revers ca humeral head adapter pooped off when the humeral head was put on.The humeral head was removed from the adapter, and then the surgeon attempted to insert it again.It appeared that the adapter was not sitting with a really good seal on the suture cup.The surgeon attempted multiple times again without success.Overall, the case was delayed forty-five minutes with additional anesthesia, while waiting for another ar-9502-42arca univers revers ca humeral head adapter to be brought into the operating room.The new adapter worked perfectly without any issues.This was discovered during a hemi arthroplasty procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9502-42arca serial/batch number (b)(6) was received for investigation.Visual inspection noted nicks/damage to both the metal and polyethylene components.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: REVERS 42MM CA ADAPTER ASSEMBLY
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 20248530
• Report Number: 1220246-2024-07713
• Device Sequence Number: 20655818
• Product Code: HSD
• UDI-Device Identifier: 00888867230392
• UDI-Public: 00888867230392
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: REVERS 42MM CA ADAPTER ASSEMBLY
• Device Catalogue Number: AR-9502-42ARCA
• Device Lot Number: 23.00412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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
• Patient Sex: Unknown