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	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "tip broke off the handle." 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 has not yet been returned.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, "tip broke off the handle." 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, "tip broke off the handle." 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, and it was received on may 20, 2025.The work order was reviewed for this lot number and no discrepancies were found.An inventory check was also performed on 11 eaches on hand and all were found to be acceptable and within specification.A complaint to sales analysis was conducted over the past two years and was found to be 0.0023%.Deroyal reviewed the returned sample and observed that the cotton tip was not glued to the tip of the stick and could be removed with little to no force.A supplier corrective action request (scar) was issued to the supplier for this issue.The supplier reviewed the last four device history records (dhrs) of the dissectors, complaint records, and manufacturing process.Upon review of the sample returned from the customer, it was found that there was an inadequate glue application on the dissector.With the review of the last four dhrs, all dissectors were found to be within specification.Training records were also inspected and confirmed that all operators were trained to the current version of the work instructions.The investigation also identified that a previous complaint was reported due to glue operators using a slightly different method when apply tape which could cause the glue to be misplaced.Root cause: after inspection of the sample received, the root cause was determined to be an inadequate glue application on the dissector.Corrective and preventive actions: work instructions were updated with more specific guidance on the tape-wrapping process.While production associates were trained on the current version, because of the complaint they were retrained on proper inspection techniques, reinforcing visual and tactile inspection criteria, and ensuring all inspectors are aligned on updated work instruction.Training will also be reconducted every 6 months to comply with work instructions for training.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: 21937250
• Report Number: 2320762-2025-00003
• Device Sequence Number: 7837938
• 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): 07/07/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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