MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT XS 33+3MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT XS 33+3MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/25/2024, it was reported by a sales representative via email that an ar-9503xs-03 humeral insert xs did not properly insert upon impaction.This was discovered during a revers total shoulder procedure on (b)(6) 2024.The case was completed by opening a second product.
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.Upon visual inspection, it was noted that the edges around the device were damaged.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

• Brand Name: HUMERAL INSERT XS 33+3MM
• 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: 19961961
• Report Number: 1220246-2024-07142
• Device Sequence Number: 12916271
• Product Code: HSD
• UDI-Device Identifier: 00888867406469
• UDI-Public: 00888867406469
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221232
• 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): 09/27/2024

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: HUMERAL INSERT XS 33+3MM
• Device Catalogue Number: AR-9503XS-03
• Device Lot Number: 23.02383
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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