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	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.One unpackaged ar-9233 was received for investigation.The visual inspection noted that the anvil pin had broken off the end and was not returned.Visible signs of wear.Laser marks are faded.The cause remains undetermined.It is unknown how many cleaning cycles the device had been exposed to.The most likely cause of the reported failure is wear and tear.
Event or Problem Description
On 09/20/2022, it was reported by a sales representative via (b)(4) that a ar-9233 guide broach's back piece is sheared off, there is nothing to mount it on or off.This occurred during an unknown case with no patient effect reported.

• 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: 19369677
• Report Number: 1220246-2024-03630
• Device Sequence Number: 7618561
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 051724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown