MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPNG-1/2X1"-STRL- 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-055
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "neuro sponge broke into two pieces while in use, the piece was found lying in the incision." deroyal industries requested return of the sample, but it has not yet been returned.A supplier corrective action request (scar) has been sent to the supplier.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "neuro sponge broke into two pieces while in use, the piece was found lying in the incision.".
Additional Manufacturer Narrative
A user facility reported, "neuro sponge broke into two pieces while in use, the piece was found lying in the incision." deroyal industries requested return of the sample and received it on 3/10/2025.The returned sample was inspected and was noted to have a partially detached string.All purchase orders that used the lot number of the reported device were reviewed and no errors were found.Deroyal also conducted an inventory check on one case of the product that was present in the distribution facility and no issues were found.During the inventory inspection, it was noted that labeling was present stating "warning: string is for identification and locating purposes only, it is not to be used for removal of the sponge from the incision." deroyal also conducted a complaint to sales ratio on this item from march 2023 to march 2025 and found it to be (b)(4).A supplier corrective action request (scar) was issued to the supplier.The supplier reviewed incoming inspection documents, material specifications, and device history records and no issues within the manufacturing process or raw materials were found.Root cause: because no issue could be found within the manufacturing process or with the materials, no root cause was able to be determined.Potential root cause: while no root cause could be confirmed, there is a potential that the string detachment was due to end-user handling.This could be due to a sharp instrument coming into contact with the material or other handling issue.Corrective or preventive actions: because no root cause could be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.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: NEURO SPNG-1/2X1"-STRL- 20/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21576391
• Report Number: 1060680-2025-00016
• Device Sequence Number: 20994413
• Product Code: EFQ
• UDI-Device Identifier: 00749756037402
• UDI-Public: 00749756037402
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: 30-055
• Device Lot Number: 24102695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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