MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, 5MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/16/2024, it was reported by a sales representative via email that two ar-9501-05p univers revers humeral stem and two ar-9502f-36cpc arthrex univers revers suture cups engaged correctly, but they were loose, along with the two ar-9503s-03 univers revers humeral insert in between.The surgeon could wiggle the implants and make them move.The screw of the two ar-9502f-36cpc arthrex univers revers suture cups was not engaging with both ar-9501-05p univers revers humeral stem.The case was completed by opening a different ar-9501-05p univers revers humeral stem, an ar-9502f-36cpc arthrex univers revers suture cup, and an ar-9503s-03 univers revers humeral insert from a different lot number.This was discovered when putting the products together before insertion in the patient during a rtsa procedure on (b)(6) 2024.The case was delayed fifteen minutes; however, it is unknown if additional anesthesia was updated.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9501-05p univers revers¿ humeral stem size 5 batch number: 24.01727 was received for investigation.The device was returned assembled to an ar-9502f-36cpc univers revers suture cup, 36 batch: 23.05410.Upon visual evaluation, it was noted that the bullet nose screw of the returned ar-9502f-36cpc univers revers suture cup, 36 was not sitting flush and the ar-9501-05p univers revers¿ humeral stem was not securely engaged with the ar-9502f-36cpc univers revers suture cup.Further visual inspection noted slight damage to the hex of the bullet nose screw.The bullet nose screw was then removed and it was further noted that the threads were slightly damaged and the screw had scratches on the surface.The length measurement of the bullet nose screw was taken using a caliper, cal id: 1003729, and the length of the returned component was found to be.7020 which is within the tolerance of the specification stated in drawing c15904 of.7028 ±.0079.Functional testing was then performed by attempting to assemble the two parts.It was found that the bullet nose screw was able to sit fully flush as intended and the ar-9501-05p univers revers¿ humeral stem size 5 and the ar-9502f-36cpc univers revers suture cup were able to engage securely together.The most likely cause for the reported failure can be attributed to user error.

• Brand Name: UNIVERS REVERS HUMERAL STEM, 5MM
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: jared engle ; 8009337001
• MDR Report Key: 20560091
• Report Number: 1220246-2024-08314
• Device Sequence Number: 3114119
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: (01)00888867247628(11)240701(17)290630(10)24.01727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• 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): 01/30/2025

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 HUMERAL STEM, 5MM
• Device Catalogue Number: AR-9501-05P
• Device Lot Number: 24.01727
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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