MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS HUMELOCK II; SHOULDER PROSTHESIS

Catalog Number	106-4800
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	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Defect in device packaging lead to loss of sterility.Capa: 2024-0039 has been opened to address this issue.
Event or Problem Description
During surgery, 2 of 48x19 offset head was opened and it was seen that the side wall of the plastic tray was damaged, breaking the primary sterile barrier.The white outer box was undamaged and did not show any signs of the contained defect.Approximately 10 minutes of surgical delay noted.Capa: 2024-0039 has been opened to address this issue.

• Brand Name: HUMELOCK II
• 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: 20484868
• Report Number: 3014128390-2024-00057
• Device Sequence Number: 19721053
• Product Code: HSD
• UDI-Device Identifier: 03701037300503
• UDI-Public: 03701037300503
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 106-4800
• Device Lot Number: S1182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART: 116-4800 LOT: N2201.
• Patient Sex: Unknown