MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO-SP-1/2X1/2"-STRL 20/CS30-054; GAUZE/SPONGE, INTERNAL

Model Number	30-054
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sponges when being used in the or are starting to come apart when using on the patient in surgery.Essentia has been using these for years and this is the first time this has happened.
Additional Manufacturer Narrative
A user facility reported on 4/6/2023 that, "the sponges when being used in the or are starting to come apart when using on the patient in surgery.Essentia has been using these for years and this is the first time this has happened." the sample has been requested to be returned to deroyal, but has not yet arrived.A supplier corrective action request (scar) will be sent to medsorb dominicana, s.A.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation.
Additional Manufacturer Narrative
While user facility listed that the product was available for return, deroyal industries never received the neuro sponge for evaluation.A supplier corrective action request (scar) was issued to the sponge supplier medsorb dominicana.Medsorb reviewed their device history record and found that it met all acceptance criteria.They have found no history that neuro patties separate from the string prior to use.Medsorb has had no changes to material, product design, manufacturing processes, or procedures.Root cause: was stated to be undetermined by medsorb as they found no evidence with the subject lot or historically to suggest manufacturing is the cause of the reported failure.Potential root cause: while medsorb did not determine a root cause, or potential root cause of the event, they did state that the string is intended for location or counting purposes only and that the ifu and accountability winding card includes a specific warning about this.Corrective and preventative actions: because no root cause was able to be determined, medsorb did not take any corrective or preventative actions.Deroyal calculated a complaint to sales ratio for this part.Between june 2021 and june 2023, 9,270 cases (185,400 eaches) were sold and two complaints were recorded in that same time frame.This creates a ratio of 0.000012 or 0.0012%.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-SP-1/2X1/2"-STRL 20/CS30-054
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, do ; 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: 19931675
• Report Number: 1060680-2023-00004
• Device Sequence Number: 16828242
• Product Code: EFQ
• UDI-Device Identifier: 00749756037242
• UDI-Public: 00749756037242
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 30-054
• Device Lot Number: 21061898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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