MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ORTHO TOTAL JOINT TRACECART®; GENERAL SURGERY TRAY (KIT)

Model Number	53-1831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 09/30/2024 reporting a yankauer suction broke during a surgery in the operating room.The sample was discarded and is not available for return to deroyal.A supplier corrective action request (scar) was issued to the yankauer supplier cardinal health.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
A yankauer suction broke during a surgery in the operating room.
Additional Manufacturer Narrative
A user facility medwatch report (mw5160207) was received on 10/31/2024 reporting the yankauer from ortho pack broke during surgery.No injury was reported.A supplier corrective action request (scar) was issued to the (b)(4).The device was not returned for evaluation; therefore, a root cause could not be determined by the supplier cardinal health.Cardinal health reviewed their device history record (dhr), and no anomalies related to the reported issue were observed.There have been no similar reports for this sku and lot in the past 12 months.Due to the root cause finding there were no corrective and preventive actions taken by cardinal health.Cardinal health will continue to track and trend through their monitoring programs and take actions as applicable.Deroyal reviewed the production records, and no issues were found.An inventory check of the yankauer was made by deroyal, a total of 25 of the (b)(4) was inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: ORTHO TOTAL JOINT TRACECART®
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 20358628
• Report Number: 3005011024-2024-00013
• Device Sequence Number: 20625719
• Product Code: LRO
• UDI-Device Identifier: 00749756598088
• UDI-Public: 00749756598088
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Device Model Number: 53-1831
• Device Lot Number: 60890244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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