MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OPEN HEART PACK; GENERAL SURGERY TRAY

Model Number 89-7483

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause: the root cause was determined to be an operator error at the manufacturing facility.Employees did not remove the sternum saw blade from the sealed plastic outer packaging.Employees were not adequately trained on the effect of this failure.Also, employees were not trained to clearly understand that failure to follow instructions and remove the outer packaging would cause a sterility hazard and pose a safety risk.Employees did not follow the work instructions, and work instructions were not adequate.Corrective action: photographic instructions of package removal will be provided.Additional instructions for package removal will be provided, including visual aid.Plant training will be conducted to provide employees with better understanding of the importance of ethylene oxide exposure to components.Investigation summary an internal complaint (call (b)(4)) was received indicating that a sternum saw blade contained within a convenience kit (part 89-7483, lot 53311005) contained a green sticker that said, "non-sterile." the product was discarded and not used on a patient.The sample was returned and received january 14, 2021.The product was left in a sealed plastic package that contains a green sticker indicating it is non-sterile.The work order was reviewed for discrepancies that may have contributed to the reported event.A discrepancy was identified.There was a line item for the affected component, raw material 5-51329, that states to remove from the package.A recall has been initiated.The official recall notice was sent to affected customers january 25, 2021.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A sternum saw blade packaged in a convenience kit has a green label on it that says "non-sterile.".

• Brand Name: OPEN HEART PACK
• Type of Device: GENERAL SURGERY TRAY
• 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: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 11269472
• MDR Text Key: 245097627
• Report Number: 3005011024-2021-00001
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 50749756741984
• UDI-Public: 50749756741984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-7483
• Device Lot Number: 53311005
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1