MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS TRIAL 39 +3; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS TRIAL 39 +3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
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 8/21/2023, it was reported by a sales representative via sems that a quantity of 2 ar-9530m-03 univers revers, trial humeral insert from different lots had an issue.The surgeon tried to use the device during a trial and snapped in the middle of the case.All the fragments were retrieved, and nothing was left inside the patient.The case was delayed for one minute and continued using another of the same arthroplasty device.This was discovered during a reverse total shoulder arthroplasty procedure on (b)(6) 2023, with no reported adverse event or patient harm.
Event or Problem Description
08/28/2023, additional information was provided: "how long was the delay in the procedure? - maybe a minute to locate and open a backup humeral 2 set.Date of the procedure: (b)(6) 2023.Facility account name, account number, and/or address where the procedure took place? (b)(6) medical center (bill to: 716, ship-to: 56439).What procedure was being performed? - revers total shoulder arthroplasty.Both instruments were shipped ground last week to arthrex returns.".
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.Complaint is confirmed.Functional testing was not performed due to the holes, inner diameter, and edge damage.Visual inspection identified that the hemostat holes were chipped.Also, it was observed across the edges of the trial and along the inner diameter.No particulates were returned.Functional testing was performed, and it was noticed that the device did not work as required due to the holes, inner diameter, and edge damage.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• Brand Name: UNIVERS REVERS TRIAL 39 +3
• 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: 17745478
• Report Number: 1220246-2023-07891
• Device Sequence Number: 19869975
• Product Code: LXH
• UDI-Device Identifier: 00888867062108
• UDI-Public: 00888867062108
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/07/2024

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 REVERS TRIAL 39 +3
• Device Catalogue Number: AR-9530M-03
• Device Lot Number: 250164601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown