MAUDE Adverse Event Report: ARTHREX, INC. REVERS 36MM CA ADAPTER ASSEMBLY; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	REVERS 36MM CA ADAPTER ASSEMBLY
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6)2024, it was reported by a sales representative via email that an ar-9502-36arca univers revers ca humeral head adapter 36 was attempted to be attached to the cup.Unable to marry the two products successfully.This was discovered during a rtsa revision case where a ca head was implanted.The case was completed with another ar-9502-36arca with no patient harm.Additional information received 2/28/24: the reason for the revision surgery was that the patient had stryker hardware in from a previous rtsa which was infected.The case was delayed roughly 10 minutes.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.One unpacked ar-9502-36arca serial/batch number (b)(6) was received for investigation.Upon evaluating the received device, it was found signs of wear.Functional testing with the matting part ar-9502f-36cpc batch 16.01252 found not issues attaching the univers revers¿ ca humeral head adapter 36 to the cup.No problem found.

• Brand Name: REVERS 36MM 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: 18889987
• Report Number: 1220246-2024-01438
• Device Sequence Number: 11512588
• Product Code: HSD
• UDI-Device Identifier: 00888867230378
• UDI-Public: 00888867230378
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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 36MM CA ADAPTER ASSEMBLY
• Device Catalogue Number: AR-9502-36ARCA
• Device Lot Number: 22.04047
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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