MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; PROSTHESIS, SHOULDER, CEMENTED

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 03/18/2024, a sales representative via (b)(4) reported that an ar-5400-01 glenoid targeter shaft broke during use from standard usage, and the guide was bent during the case, with no further information provided.No pieces broke inside the patient, and the case was completed without complications.This was discovered during an rtsa procedure on (b)(6) 2024, with no patient harm reported.Additional information has been received on 3/28/2024: due to the handle of the ar-5400-01 glenoid targeter shaft being bent, the targeting legs were unable to slide into the arm slots of the ar-5400-01 glenoid targeter shaft.The case was completed using a different handle with no delay.There were no adverse effects on the patient.Additional information was received on 3/29/2024: further clarification was received that the "bent" device was the ar-5400-01, targeter shaft.
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-applied excessive force during the insertion process.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 19060792
• Report Number: 1220246-2024-01859
• Device Sequence Number: 6676679
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• 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): 06/06/2025

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: GLENOID TARGETER SHAFT
• Device Catalogue Number: AR-5400-01
• Device Lot Number: 022139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2021
• 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