MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS HOOK NARROW DEPTH GAUGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	951-0030
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contaminant matter was discovered inside the cannulas of instruments in the field, as the product was not satisfactorily inspected and decontaminated.Capa-2024-0027 has been opened to address this issue.
Event or Problem Description
During spd at the hospital before surgery, a reamer, a glenoid impactor, and a depth gauge were found to have debris inside their cannulas.A photo and video was provided showing the issue.No surgical delay was noted.Capa-2024-0027 has been opened to address this issue.

• Brand Name: HOOK NARROW DEPTH GAUGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 19635355
• Report Number: 3014128390-2024-00035
• Device Sequence Number: 8610248
• Product Code: LXH
• UDI-Device Identifier: 03701037316917
• UDI-Public: 03701037316917
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 951-0030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART: 902-0900 LOT: UNK
• Patient Sex: Unknown