MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS TRIAL 36 +6; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS TRIAL 36 +6
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
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 10/4/2023, it was reported by a sales representative via (b)(4) that an ar-9530s-06 univers revers trial 36 + 6 was damaged from heavy use.This was discovered during an unspecified procedure.There were no adverse effects for the patient.This occurred during use with no patient harm.Additional information has been requested.On 10/9/2023, the sales representative provided the following information via email: this occurred during a reverse total shoulder procedure on (b)(6) 2023.The device looked like it was getting close to breaking, but it did not break yet.Nothing broke inside the patient.They briefly used the complaint device but then went up to the next trial size to complete the procedure successfully.There was no case delay reported.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9530s-06 batch 348779 was received for evaluation.Visual inspection noted that the inside and outside geometry of the circle was damaged.The material around the circle shows nicks.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Device manufacturing date 2020.

• Brand Name: UNIVERS REVERS TRIAL 36 +6
• 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: 18038433
• Report Number: 1220246-2023-08463
• Device Sequence Number: 15496677
• Product Code: LXH
• UDI-Device Identifier: 00888867062160
• UDI-Public: 00888867062160
• 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,Followup
• Report Date (Section B): 01/15/2025

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 REVERS TRIAL 36 +6
• Device Catalogue Number: AR-9530S-06
• Device Lot Number: 348779
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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