MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. KITTNER, LAPROSCOPIC BLUNT DISSECTOR; DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	28-0801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the tip broke off." no injuries were reported, but a delay of procedure was noted.No specifics on length of delay or any outcomes related to the delay were given.Deroyal industries, inc.Has requested return of the device, however it was unavailable for return.A supplier corrective action request (scar) has been issued 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, "the tip broke off." no injuries were reported, but a delay of procedure was noted.No specifics on length of delay or any outcomes related to the delay were given.
Additional Manufacturer Narrative
A user facility reported, "the tip broke off." no injuries were reported, but a delay of procedure was noted.No specifics on length of delay or any outcomes related to the delay were given.Deroyal industries, inc.Has requested return of the device, however it was unavailable for return.A review of any corrective and preventive actions (capas) was conducted and no applicable capas were found.An inventory check of 11 kittners were inspected each of these products were within specification.A complaint to sales ratio was conducted over the past two years and was found to be (b)(4).A supplier corrective action request (scar) was issued to the manufacturer and returned.The supplier conducted a review of four other lots of kittners as the lot number was not provided.The current manufacturing lot and complaint records were also reviewed by the supplier.Through these investigations, all products were found to be within specification and no issues were found.Root cause: because the device nor the lot were given or returned and no issues could be found during the investigation, 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.

• Brand Name: KITTNER, LAPROSCOPIC BLUNT DISSECTOR
• Common Device Name: DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21937249
• Report Number: 2320762-2025-00004
• Device Sequence Number: 7837937
• Product Code: GDI
• UDI-Device Identifier: 00749756025355
• UDI-Public: 00749756025355
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 28-0801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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