MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS GLENOID RESURFACING REAMER; BONE REAMER

Catalog Number	906-0014
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
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-2024-0027 has been opened to address this issue.
Event or Problem Description
Instrument kit was shipped out to the doctor for a case on (b)(6) 2024.The instrument kit was received, checked in, and sterilized per hospital protocol.Upon preparing for the imminent surgery, the kit was opened.The reverse glenoid shoulder tray was taken out.It was discovered that two of the included bone reamers had bone matter in the cannulas.This was not caught by the hospital spd as they do not individually inspect items.Surgeon and representative expressed discontent that the bone matter was not caught before shipment out of fx warehouse.Resulted in an hour of surgical delay.Capa-2024-0027 is being opened to address the issue.

• Brand Name: GLENOID RESURFACING REAMER
• Common Device Name: BONE REAMER
• 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
• Manufacturer Contact: tristan mahler ; 15920 addison road; addison, TX
• MDR Report Key: 19050955
• Report Number: 3014128390-2024-00019
• Device Sequence Number: 7308390
• Product Code: LXH
• UDI-Device Identifier: 03701037312117
• UDI-Public: 03701037312117
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: Other
• Device Catalogue Number: 906-0014
• Device Lot Number: N3517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/05/2024
• 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: 906-0026 LOT: N1739
• Patient Sex: Unknown