MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID CORRECTION REAMER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERSAL GLENOID CORRECTION REAMER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that an ar-9126rc correction reamer broke, and an ar-9165cdg assembly, an ar-9545-t15-01 driver shaft, an ar-9545-t15-02 driver shaft, and an ar-9545-t15-03 driver shaft are bent.This occurred during use in a case with no patient effect.No piece broke off inside the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Upon visual inspection, it was noted that the head and the ring of the universal glenoid correction reamer had broken off.No broken pieces were returned.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.The device was manufactured in 2015.

• Brand Name: UNIVERSAL GLENOID CORRECTION REAMER
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19034847
• Report Number: 1220246-2024-01803
• Device Sequence Number: 12771685
• Product Code: LXH
• UDI-Device Identifier: 00888867057616
• UDI-Public: 00888867057616
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/23/2024

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: UNIVERSAL GLENOID CORRECTION REAMER
• Device Catalogue Number: AR-9126RC
• Device Lot Number: 250140703
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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