MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. NEURO SPONGE PATTIES

Model Number	30-154
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the first complaint of this type for this product group.There have been 5 total complaints reported for this product group since april 2020 for a complaint rate of 0.328%.This investigation is ongoing and root cause has yet to be determined.A scar has been initiated and a follow up report will be submitted once additional information is received.
Event or Problem Description
(b)(4) 1/4 x 1/4 neuro patties were used.The surgical technologist noted that the x-ray detectable line in a patty had fallen off onto the surgical back table after the patty was removed from the patient.Procedure: lumbar laminectomy, no patient impact reported.
Additional Manufacturer Narrative
Additional information was received on 6/1/2022 with the completion of the requested scar.Manufacturing records including non-conformance logs and complaint logs from 2019 to 2022 were reviewed and this was found to be the first event of this type, with no history of similar defects.As the lot number of the reported product was not available, a case of another lot was pulled for testing by the supplier.Thirty sponges were tested in water soaking overnight and found to have no discrepancies.An under water pull test was performed on 20 sponges and no discrepancies were found.Rough handling and pulling tests were performed on the rest of case with no discrepancies.The investigation performed by the supplier for the scar identified no discrepancies and a root cause was not able to be determined.This was assessed to be a single isolated incident and therefore no corrective actions were taken.No further information is available at this time.A follow up report will be submitted if additional information becomes avilable.

• Brand Name: NEURO SPONGE PATTIES
• Common Device Name: NEURO SPONGE PATTIES
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: mary catherine reeves ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 14168337
• Report Number: 1060680-2022-00002
• Device Sequence Number: 17588338
• Product Code: EFQ
• UDI-Device Identifier: 00749756037808
• UDI-Public: (01)00749756037808
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Model Number: 30-154
• Device Catalogue Number: 30-154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/24/2022
• 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