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	06/27/2024
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 06/28/2024, it was reported by a sales representative via sems- (b)(4) that an ar-9233 guide broach back cap sheared from inner sleeve.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on 7/2/2024: this event occurred while inside the patient, and all fragments were retrieved.The surgeon had already broached enough, and the instrument was broken upon final impaction, so it broke right when they finished with the ar-9233 guide broach.This was discovered during a total shoulder arthroplasty (eclipse/vaultlock) procedure on (b)(6)2024.There was no delay in the case, and it was completed successfully.Photos are attached of the complaint device.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9233, guide broach, batch 121508, was received for investigation.Visual evaluation found that the anvil was broken off on the distal end and was not returned for investigation.Additionally, signs of wear and tear were visible throughout the device: the laser marks were faded, discoloration, oxidation and strike marks.The most likely cause is attributed to wear and tear due to repeated use of the device.

• 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: 19764007
• Report Number: 1220246-2024-06799
• Device Sequence Number: 8541796
• Product Code: MDM
• UDI-Device Identifier: 00888867059443
• UDI-Public: 00888867059443
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/23/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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