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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/27/2023, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 universal quick connect handle had the tip of the handle break off in the ar-9510rg-c arthrex univers revers reamer guide.The case was completed by swapping for another device without adverse effects on the patient.This was discovered during a tsa procedure on (b)(6) 2023, with no reported patient harm.Additional information received on 1/15/2023: the case was completed using a 2nd handle inside the set.There was a 10 minute delay in the case to get the drill guide removed.All fragments were retrieved.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18612411
• Report Number: 1220246-2024-00627
• Device Sequence Number: 14045664
• Product Code: MDM
• UDI-Device Identifier: 00888867061798
• UDI-Public: 00888867061798
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/27/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/27/2025
• 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