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	Insufficient Information (4580)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/15/2024, it was reported by a sales representative via sems-(b)(4) that an ar-9233 guide broach broke.This occurred during a case they were still able to complete the case with no issue.No additional information was provided, and additional information has been asked.
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-9233 serial/batch number (b)(6) was received for investigation.Functional testing could not be conducted because the device was received in a damaged condition.Upon visual inspection, it was determined that the distal end of the pegged glenoid guided broach anvil had broken off and was not submitted for investigation.The device exhibited significant wear and tear.The reported condition is most likely caused by overstressing a device damaged naturally and inevitably because of normal wear or aging.

• 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: 19905086
• Report Number: 1220246-2024-07018
• Device Sequence Number: 8732094
• 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): 09/26/2024

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: 052144
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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