MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS REDUCTION HELPER; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVERS REDUCTION HELPER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-9545 glenosphere reduction tool broke.This occurred during a case on (b)(6) 2023, a backup was used to complete the case.No additional information was provided.Additional information has been requested.Additional information was provided on (b)(6) 2023, it was reported that this event occurred during a tsa case.All fragments were retrieved from the patient.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the distal end of the univers revers revers helper is broken off.The cause of this condition usually is the excessive force used to pry and/or leverage the device.The cause remains undetermined.

• Brand Name: UNIVERS REVERS REDUCTION HELPER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16870904
• Report Number: 1220246-2023-06674
• Device Sequence Number: 14822416
• Product Code: MDM
• UDI-Device Identifier: 00888867141636
• UDI-Public: 00888867141636
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/04/2023

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: UNIVERS REVERS REDUCTION HELPER
• Device Catalogue Number: AR-9545
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown