MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OPEN HEART #2 ON PUMP PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-7103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Yankauer open tip broke off during surgery.
Additional Manufacturer Narrative
A complaint was received on 4/28/2025 reporting yankauer open tip broke off during surgery.The device was changed out and surgical site inspected, with no broken pieces discovered.No adverse event was reported.The actual sample was not available to be returned for evaluation.However, a photo of the device was provided.A supplier corrective action request (scar) was issued to the drape supplier cardinal health company.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.
Additional Manufacturer Narrative
A complaint was received on 4/28/2025 reporting yankauer open tip broke off during surgery.The device was changed out and surgical site inspected, with no broken pieces discovered.No adverse event was reported.The actual sample was not available to be returned for evaluation.However, a photo of the device was provided.A supplier corrective action request (scar) was issued to the yankauer supplier cardinal health company.Cardinal health company determined photos were returned and the reported issue was observed.Since the product was not returned for evaluation, a definitive root cause could not be determined.Cardinal health company determined that the device history record (dhr) was reviewed, and no anomalies related to the reported issue were observed during the manufacturing of this product.In addition, a review of our internal monitoring processes did not indicate a trend for similar reported events.Based on this information, no corrective actions are warranted at this time.Cardinal health will continue to track and trend through their monitoring programs and take actions as applicable.Deroyal root cause was determined to be that the defect appears to be related to a material integrity issue occurring during or after the molding process at the supplier level.As no visual abnormalities were present in the sampled inventory and no deviations were found in deroyal's assembly process, the issue is likely isolated to a batch-level manufacturing anomaly at the raw material supplier.There were no corrective or preventive actions taken by deroyal due to the root cause determination.Production records were reviewed, and no issues were found.An inventory check of the yankauer was made by deroyal, a total of 25 of (b)(4) were 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: OPEN HEART #2 ON PUMP PACK
• 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: 21941461
• Report Number: 3005011024-2025-00003
• Device Sequence Number: 18279675
• Product Code: LRO
• UDI-Device Identifier: 00749756741071
• UDI-Public: 00749756741071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/18/2025

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: 89-7103
• Device Lot Number: 61261458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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