MAUDE Adverse Event Report: CATALYST ORTHOSCIENCE INC. ARCHER R1 REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS

Model Number	1230-7504-002
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial surgery was performed on (b)(6) 2023.Device had been implanted for approximately 1 year 3 months.Patient reported a fall while walking dog to surgeon when being evaluated for possible dislocation.Following revision, it was reported that the poly insert had dissociated from the humeral stem.Revision surgeon removed poly insert 36mm +4 p/n 1230-7504-002 and implanted new poly insert 36mm + 0 p/n 1230-7518-001, humeral spacer +8mm p/n 1230-7522-001, and spacer locking screw p/n 1230-7521-001.
Additional Manufacturer Narrative
The dhr for the polyethylene insert was reviewed and, when released for use, met design and manufacturing requirements.There were no non-conformities associated with the component that may have contributed to the event identified during manufacturing.The devices was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.The returned poly insert was evaluated and found nicked, deformed, and scratched.It is not known when the deformation of the poly insert took place and likely occurred after dissociation or during explanation.Catalyst has identified two factors thar could contribute to dissociation.One factor is not following the surgical technique and not assembling the poly insert completely within the humeral stem.The other factor is the poly insert experiencing a high force not in-line with the insert / stem interface.

• Brand Name: ARCHER R1 REVERSE SHOULDER SYSTEM
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): CATALYST ORTHOSCIENCE INC.; 14710 tamiami trail n.; suite 102; naples FL 34110
• Manufacturer Contact: dale davison ; 14710 tamiami trail n.; suite 102; naples, FL 34110 ; 2393259976
• MDR Report Key: 19354755
• Report Number: 3012552981-2024-00075
• Device Sequence Number: 15320089
• Product Code: PHX
• UDI-Device Identifier: 00811596030452
• UDI-Public: (01)00811596030452(17)270708(211071)
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: 202611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1230-7504-002
• Device Catalogue Number: 1230-7504-002
• Device Lot Number: 211071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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