MAUDE Adverse Event Report: ARTHREX, INC. GLENOID RMR SFT W/GLOVE PROTECTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID RMR SFT W/GLOVE PROTECTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 10/24/2022 by a sales representative via sems that an ar-9233, ar-9211 and ar-9239 devices were damaged during use.During case the straight shaft reamer is bent which caused an issue when drilling with 4.5 drill bit.4.5 drill bit was extremely dull.Impactor broke while impacting for vaultlock.This was discovered during a case and broke inside the joint space.
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 device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to wear and tear.

• Brand Name: GLENOID RMR SFT W/GLOVE PROTECTOR
• 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: 19359140
• Report Number: 1220246-2024-03575
• Device Sequence Number: 17727891
• Product Code: LXH
• UDI-Device Identifier: 00888867058965
• UDI-Public: 00888867058965
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: GLENOID RMR SFT W/GLOVE PROTECTOR
• Device Catalogue Number: AR-9211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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