MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS RMR GD-135 (NEUTRAL); ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVS RMR GD-135 (NEUTRAL)
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, during a rtsa using our modular glenoid system, during the humeral cup reaming, the surgeon could not get the humeral cup reamer guide to stay within the broach.The surgeon could not get a tactile feel that the guide would stay in place and this caused him to ream higher than he wanted to.The surgeon used our back-up set to try different humeral cup reamers, but those too did not sit within the broach the way they were designed to do so.The black ring around the humeral cup reamers that allows the guide to click within the broach has been worn and defective.The case was completed by the surgeon reaming over the pin and securing the cup within the humerus and he was successful with the rtsa case.
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 device was not received for evaluation.Based off the information provided, the complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• Brand Name: UNIVERS REVS RMR GD-135 (NEUTRAL)
• 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: 19494469
• Report Number: 1220246-2024-05306
• Device Sequence Number: 12539338
• Product Code: MDM
• UDI-Device Identifier: 00888867061798
• UDI-Public: 00888867061798
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/07/2024

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: UNIVERS REVS RMR GD-135 (NEUTRAL)
• Device Catalogue Number: AR-9510RG-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown