MAUDE Adverse Event Report: ARTHREX, INC. UNI REV HUMERAL RESECTION GUIDE 135/155; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNI REV HUMERAL RESECTION GUIDE 135/155
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
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) 2023, it was reported by a sales representative via sems that an ar-9507rgdp-3 univers revers humeral resection guide malfunctioned during a reverse total shoulder arthroplasty procedure on (b)(6) 2023.During humeral preparation, when securing the compromised resection guide with the 2.4mm breakaway pins to the patient, the surgeon had difficulty driving the appropriately designated 2.4mm pin through one of the available resection guide holes.A couple of alternative 2.4mm pins were attempted without success.The case delay was approximately 1 minute while alternative holes were utilized.Post-surgical inspection appeared to show a metal burr within the resection hole preventing the pins from being driven.The instrument did not break.There was not an unplanned incision.A second surgery was not necessary.The device will be returned for evaluation.The event did not occur during the initial use of the device.This occurred during use with no patient harm.Additional information has been requested.On (b)(6) 2023, the sales representative stated the following information via phone: nothing broke inside the patient.When the device was inspected post-surgically and outside the patient, it appeared to show a metal burr within the resection hole, preventing the pins from being driven.The procedure was completed successfully with a case delay of 1 minute, and no other adverse effect was reported.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the surface of the device was damaged, and all the edges had been chipped.The laser marks faded.Functional testing noted that the pin 2.4 mm did not go through one of the device slots due to the edge's damage.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: UNI REV HUMERAL RESECTION GUIDE 135/155
• 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: 17556182
• Report Number: 1220246-2023-07511
• Device Sequence Number: 19742804
• Product Code: LXH
• UDI-Device Identifier: 00888867266025
• UDI-Public: 00888867266025
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/02/2023

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: UNI REV HUMERAL RESECTION GUIDE 135/155
• Device Catalogue Number: AR-9507RGDP-3
• Device Lot Number: 051817
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/02/2023
• 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