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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a total shoulder arthroplasty the 6mm drill bit would not attach properly to the shaft and the device is sticking.It finally engaged and the case was completed with no further issues and the patient is fine.
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.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photos provided.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• 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: 19358347
• Report Number: 1220246-2024-03566
• Device Sequence Number: 6341845
• Product Code: LXH
• UDI-Device Identifier: 00888867058965
• UDI-Public: 00888867058965
• Combination Product (Y/N): N
• 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): 05/21/2024

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
• Device Lot Number: 14981507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown