MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. LUMBAR LAMINECTOMY TRAY; GENERAL SURGERY TRAY (KIT)

Model Number	89-3564
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical patty in the pack had a blue x-ray detectable strip that detached from the patty.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on (b)(6) 2022 reporting the surgical patty in the pack had a blue x-ray detectable strip that detached from the patty.A supplier notification letter was sent to the vendor integra lifesciences sales, ll.To make them aware of the issue.Root cause: the actual sample has not been returned for evaluation.Therefore, deroyal was unable to determine the true root cause.Corrective action: a corrective action has not been taken due to the root cause determination.An inventory check was made by deroyal, a total of 30 patties 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: LUMBAR LAMINECTOMY TRAY
• 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: 13505786
• Report Number: 3005011024-2022-00003
• Device Sequence Number: 5115393
• Product Code: LRO
• UDI-Device Identifier: 00749756559270
• UDI-Public: 00749756559270
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 89-3564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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