MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-dec-2025, it was reported by a sales representative via (b)(4) that when trying to assemble the vip glenoid targeter, slot b of the ar-5400-01 glenoid targeter shaft was dented, and the targeter leg could not be inserted onto the targeter shaft.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-5400-01 vip¿ glenoid targeter, titanium shaft batch 022139 was received for evaluation.During the visual evaluation, it was noted that the instrument shows significant damage throughout, including nicks in the slots.Damage to the edges of the slot will prevent the device from working as intended.A functional test was not performed because the observed damage on the device could compromise the mating part.The most likely cause of the reported failure is wear and tear on the device due to repetitive use.Instrument manufacturing date 2021.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 23933833
• Report Number: 1220246-2025-05913
• Device Sequence Number: 9527856
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: (01)00888867315334(11)211015(10)022139
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/13/2026

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?: Yes
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown