MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS CENTERED HEAD CRCO 48X18; SHOULDER PROSTHESIS

Catalog Number	106-4818
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Wall of plastic tray was damaged, compromising the seal.Capa-2024-0039 has been opened to address this issue.
Event or Problem Description
In a case with the surgeon on (b)(6) 2025, a 48x18 centered head was opened during surgery and the tray was seen to be cracked in a manner that breaches the sterile barrier.The tray has cracked in the corner opposite peeling corner, resulting in chipping of the sealing lip.The tyvek barrier was peeled back approximately 1 inch as a result of the damage.The component itself, and the plastic wrapped seal, appear to not have been compromised.No surgical delay was noted.Capa-2024-0039 has been opened to address this issue.

• Brand Name: CENTERED HEAD CRCO 48X18
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer Contact: tristan mahler ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 22039760
• Report Number: 3014128390-2025-00024
• Device Sequence Number: 15718511
• Product Code: HSD
• UDI-Device Identifier: 03701037300428
• UDI-Public: 03701037300428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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 Expiration Date: 05/01/2026
• Device Catalogue Number: 106-4818
• Device Lot Number: P1660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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