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

Model Number	GLENOID TARGETER HANDLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/15/2025, it was reported by a sales representative via (b)(4) that an ar-5400-02 targeting handle prongs are bent and will not seat.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-5400-02 serial/batch number (b)(6) was received for evaluation.A visual evaluation found a slight bend in the prongs.Functional testing was performed with well know good parts, and it was noted resistance when the ar-5400-04 vip¿ glenoid targeter, locking nut was screwed onto the ar-5400-02.The inside diameter was tested according to drawing c17095 at revision 3.Ø.551 ±.001 result: pass with friction.The most likely cause of the reported failure is damage to the device, which prevents an easy couple with the mating part.The device's manufacturing date.12/22/2023.

• Brand Name: GLENOID TARGETER HANDLE
• 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: 21549903
• Report Number: 1220246-2025-00850
• Device Sequence Number: 8179544
• Product Code: KWS
• UDI-Device Identifier: 00888867315341
• UDI-Public: (01)00888867315341(11)240401(10)052348
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 04/15/2025

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 HANDLE
• Device Catalogue Number: AR-5400-02
• Device Lot Number: 052348
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2024
• 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