MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. NS KITTNER DISSECTORS 9/16X1/4, 5 EA /PK, 50 PKS / CA; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-101NS
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "sponges in the head and neck thyroid pack were shredding as dr was using them in parathyroid case." deroyal industries requested the return of the device, however it was unavailable for return.Deroyal reviewed failure modes and effects analysis (fmea) and any checked for any applicable corrective and preventive actions (capas).No issues were found with the fmea review and no applicable capas were found related to this complaint.An inventory check was also performed on 13 cases (650 packs) of kittners and no issues were found.The device history record was reviewed including the quality control inspection report.All checks were found to be acceptable.A complaint to sales ratio was calculated over the past two years and was found to be (b)(4).Root cause: because the device was not able to be returned and no issues were found within the manufacturing review, no root cause was able to be determined.Corrective and preventive actions: because no root cause was able to 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.
Event or Problem Description
A user facility reported, "sponges in the head and neck thyroid pack were shredding as dr was using them in parathyroid case.".

• Brand Name: NS KITTNER DISSECTORS 9/16X1/4, 5 EA /PK, 50 PKS / CA
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21150408
• Report Number: 3010452421-2024-00008
• Device Sequence Number: 21115918
• Product Code: GDY
• UDI-Device Identifier: 00749756163002
• UDI-Public: 00749756163002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 30-101NS
• Device Lot Number: 60691579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/14/2025
• 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