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

Model Number	UNIVERS REVERS TRIAL 39 +3
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-9530m-03 univers revers trial 39 +3 was damaged.When trying to remove the trial on (b)(6) 2022, it got stuck after re-dislocating the arm.As he was getting the insert out, damaged the plastic trial insert.This was discovered during use with no impact to the patient.Additional information was requested.On 02/24/2022, the sales representative provided the following information via email: the event occurred in a reverse tsa procedure, the damage occurred while trying to remove the device.The part broke inside the patient, no fragments were left behind.To complete the procedure, another poly was opened, and there was no impact to the patient.
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.

• Brand Name: UNIVERS REVERS TRIAL 39 +3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13757961
• Report Number: 1220246-2022-04597
• Device Sequence Number: 4859408
• Product Code: LXH
• UDI-Device Identifier: 00888867062108
• UDI-Public: 00888867062108
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/14/2022

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: 250140601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/14/2022
• Date Device Manufactured: 01/21/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown