MAUDE Adverse Event Report: ARTHREX, INC. SIZE 15 LEG, GLENOID TARGETER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SIZE 15 LEG, GLENOID TARGETER
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 01/10/2025, it was reported by a sales representative via (b)(4).That an ar-5400-15 vip¿ glenoid targeter, size 15 leg was bent during a case.This was discovered during a procedure, with no reported patient harm.Additional information was received on 1/13/2025: this was discovered during a reverse shoulder procedure on 12/30/2024.An extra guide was used to complete the case.There was no case delay.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, which may include improper bone preparation, misaligned insertion, and/or the use of excessive force.The complaint allegation was not confirmed.No evidence of the failure was received.

• Brand Name: SIZE 15 LEG, GLENOID TARGETER
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21315276
• Report Number: 1220246-2025-00225
• Device Sequence Number: 12815514
• Product Code: KWS
• UDI-Device Identifier: 00888867315426
• UDI-Public: 00888867315426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/09/2025

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: SIZE 15 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown