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

Model Number	UNIVERS REVERS REDUCTION HELPER
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
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 12/16/2022, it was reported by a sales representative via sems that a ar-9545 glenosphere reduction tool broke.This occurred during a case in the middle of trailing an eclipse head size, the surgeon wanted to dislocate the shoulder and remove the trial, when the retractor snapped.The broken piece was retrieved and set aside, another retractor was used to complete the case.There was no patient effect reported.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-9545 serial/batch number ar07103901 was received for investigation.The visual evaluation confirms the tip broke off previously to receive it for investigation.The device has evidence of wear and tear, the root cause of the reported failure mode is undetermined.However, this event is most likely caused by prying/levering the device against hard bone or other instrumentation during use.
Additional Manufacturer Narrative
Complaint confirmed.One unpacked ar-9545 serial/batch number (b)(6) was received for investigation.The visual evaluation confirms the tip broke off previously to receive it for investigation.The device has evidence of wear and tear, the root cause of the reported failure mode is undetermined.However, this event is most likely caused by prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: UNIVERS REVERS REDUCTION HELPER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 16087491
• Report Number: 1220246-2023-06032
• Device Sequence Number: 6529705
• 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,Followup,Followup
• Report Date (Section B): 03/16/2023

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
• Device Lot Number: AR07103901
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 12/16/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/14/2023; 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown