MAUDE Adverse Event Report: ARTHREX, INC. SIZE 13 LEG, GLENOID TARGETER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SIZE 13 LEG, GLENOID TARGETER
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
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 04/28/2025, it was reported by a sales representative via (b)(6) that an ar-5400-13 size 13 leg glenoid targeter was unable to be inserted into the shaft guides.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-5400-13 size 13 glenoid targeter leg batch number: ar10040501 was received for investigation.Visual evaluation of the returned device noted scratches along the edge of the device.Functional testing was performed by attempting to insert the returned ar-5400-13 size 13 glenoid targeter leg into a known good ar-5400-01 glenoid targeter titanium shaft and it was found that the returned device could not be inserted as intended into the mating part.The cause can be attributed to a supplier manufacturing issue being addressed by ncr-26054.Refer to record cross reference.Refer to investigation photos.Complaint allegation is confirmed.

• Brand Name: SIZE 13 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: 22027813
• Report Number: 1220246-2025-02062
• Device Sequence Number: 8492716
• Product Code: KWS
• UDI-Device Identifier: 00888867315402
• UDI-Public: (01)00888867315402(11)230630(10)AR10040501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/14/2025

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 13 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-13
• Device Lot Number: AR10040501
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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