MAUDE Adverse Event Report: ARTHREX, INC. PEGGED GLENOID TRIL & DRILL GUIDE CADDY; MANUAL INSTR, GENERAL SURGICAL

Model Number	PEGGED GLENOID TRIL & DRILL GUIDE CADDY
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
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.Complaint confirmed.Visual inspection identified corrosion spots inside the caddy.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to improper detergent/cleaning process used.
Event or Problem Description
It was reported by the agency that the following devices are corroded: ar-9231-01pp qty 1; ar-9231-02pp qty 1; ar-9231-03pp qty 1; ar-9231-04pp qty 1; ar-9217cpp qty 2; ar-9225ck qty 1; ar-9225cp qty 1.

• Brand Name: PEGGED GLENOID TRIL & DRILL GUIDE CADDY
• 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: 19548313
• Report Number: 1220246-2024-05881
• Device Sequence Number: 6716227
• Product Code: MDM
• UDI-Device Identifier: 00888867137769
• UDI-Public: 00888867137769
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: PEGGED GLENOID TRIL & DRILL GUIDE CADDY
• Device Catalogue Number: AR-9225CP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 06/17/2024
• 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