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

Model Number	BROACH, PEGGED GLENOID
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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
It was reported that during a shoulder prosthesis surgery the impact head of the device broke off.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully without changing the device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the anvil was broken off at the pin assembly of the pegged glenoid, guided broach.Functional testing was not performed due to the damage.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated insertion and/or removal processes of the device and extended use in the field.Manufacturing date 2016.

• 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: 21633146
• Report Number: 1220246-2025-01005
• Device Sequence Number: 20719712
• Product Code: MDM
• UDI-Device Identifier: 00888867059443
• UDI-Public: (01)00888867059443(11)161031(10)051634
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: BROACH, PEGGED GLENOID
• Device Catalogue Number: AR-9233
• Device Lot Number: 051634
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2016
• 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