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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/24/2023, it was reported by a sales representative via sems that an ar-9530s-06 trial humeral insert 36 +6 broke in half.This occurred during a reverse total shoulder arthroplasty on (b)(6) 2023.There was no additional information provided.Additional information has been requested.
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.
Additional Manufacturer Narrative
The complaint cannot be confirmed without the return of the device for evaluation.Per event description:" an ar-9530s-06 trial humeral insert 36 +6 broke in half." it is concluded that the instrument was broken into two pieces.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is user error for applying excessive force during use.Per dfu-0023-eor3_fmt_en.I.Cautions.6.Flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.7.Do not overstress the device or use device to pry tissue.

• 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: 17152516
• Report Number: 1220246-2023-06931
• Device Sequence Number: 17126215
• Product Code: LXH
• UDI-Device Identifier: 00888867062160
• UDI-Public: 00888867062160
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/16/2023

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 TRIAL 36 +6
• Device Catalogue Number: AR-9530S-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown