MAUDE Adverse Event Report: ARTHREX, INC. 24MM +2 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM +2 LAT BASEPLATE, MODULAR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 4/04/2023, it was reported by a sales representative via email that an ar-9100-08p univers ii humeral stem 8mm had an inclination screw locked in position when opened.The case was completed successfully by using a bigger size (9) primary stem.This was discovered during a reverse total shoulder procedure, with no patient harm.Additional information received on 4/05/2023: the locked inclination screw was discovered during implantation.The glenoid fracture was caused by screwing the glenosphere to the base plate.Additional information received on 4/5/2023: the faulty ar-9100-08p arthrex univers ii humeral stem 8mm was discovered prior to implantation.The surgeon had originally planned for an rsa procedure but due to a fracture of the glenoid while screwing in the ar-9560-24-2 baseplate and an ar-9564-2433-lat glenosphere.It was not caught until the glenosphere was inserted and the entire baseplate rotated and shifted.The surgeon proceeded by removing the glenosphere with a removal device and the baseplate was pulled out by hand.The case was completed using an ar-9100-09pc arthrex univers ii stem, size 9.Additional information received on 4/6/2023; the procedure was delayed 2 hours and additional anesthesia was administered to the patient.Even though a size 9mm stem was used to complete the case, the surgeon did not need to broach the canal larger.Instead, the ar-9100-09pc arthrex univers ii stem, size 9 was implanted slowly allowing the bone to expand before the final impaction.The surgeon is planning on a revision surgery but has not been scheduled yet.
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
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the glenosphere.

• Brand Name: 24MM +2 LAT BASEPLATE, MODULAR
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 16844989
• Report Number: 1220246-2023-06644
• Device Sequence Number: 6823682
• Product Code: PHX
• UDI-Device Identifier: 00888867296497
• UDI-Public: 00888867296497
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• 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): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24MM +2 LAT BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown