MAUDE Adverse Event Report: ARTHREX, INC. BROACH, PEGGED GLENOID; MANUAL INSTR, GENERAL SURGICAL

Model Number	BROACH, PEGGED GLENOID
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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 12/01/2025, it was reported by a sales representative via (b)(4) that an ar-9233 broach seized up internally during use.No case involvement.Additional information was received from the rep on 12/8/25.The device was "sludgy and sticky" with no way to clean the bio burden.The issue was discovered after a total shoulder arthroplasty with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9233, broach, was received for investigation.Visual investigation noted that the device had significant surface damage along the body.The laser marks were faded; there were strike marks on the handle and the edges were dull.Functional testing noted some resistance when moving the device up and down.The most likely cause of the reported failure can be attributed to a combination of normal wear-and-tear from repeated use and insufficient cleaning/reprocessing, resulting in the buildup of residue and bioburden inside the instrument.This combination can restrict internal movement and cause the device to become ¿sludgy,¿ sticky, and unable to function properly.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: BROACH, PEGGED GLENOID
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23863689
• Report Number: 1220246-2025-05749
• Device Sequence Number: 9350250
• Product Code: MDM
• UDI-Device Identifier: 00888867059443
• UDI-Public: 00888867059443
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/12/2026

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: BROACH, PEGGED GLENOID
• Device Catalogue Number: AR-9233
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown