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

Catalog Number	951-0023
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contaminant matter was discovered inside the cannula of an instrument in the field, as the product was not satisfactorily inspected and decontaminated.Capa-2025-0030 has been opened to address this issue.
Event or Problem Description
During a case with the surgeon on (b)(6) 2025, the drill guide was discovered to have bone debris obstructing the cannula.The instrument was flushed with betadine wash in the surgical suite, as the surgeon felt the debris was at least sterile.There was no surgical delay.A photo returned does confirm the issue.The instrument set in question has been identified.It was shipped to the distributor, and is not yet returned to fx shoulder solutions.The case performed on 23-apr-2025 by the distributor was the first case performed during this time.The instrument in question was not adequately inspected or cleaned by fx shoulder solutions warehouse staff.Capa-2025-0030 has been opened to address this issue.

• Brand Name: DRILLING GUIDE 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: 21963608
• Report Number: 3014128390-2025-00020
• Device Sequence Number: 7151822
• Product Code: LXH
• UDI-Device Identifier: 03701037316894
• UDI-Public: 03701037316894
• 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): 05/05/2025

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: 951-0023
• Device Lot Number: T2063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/05/2025
• 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
• Patient Sex: Unknown