MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,SUTURE REMOVAL,MTL IRIS&ADSON FCP

Catalog Number	DYNJ07254AH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "today i was using a pair of scissors in the suture removal kit and they broke apart into 2 different pieces in my hands".
Additional Manufacturer Narrative
The customer reported that a pair of scissors in the suture removal kit "broke apart into 2 different pieces" in the reporter's hands; no injury occurred.A photo was received for the investigation, and the photo depicts scissors in two pieces as the scissors are separated at the hinge, with black marks around the hinge and on the tip of the instrument; however, there are no cracks or marks on the hinge or rest of the instrument, and no additional defects were noted.The reported problem was confirmed based on the photo depicting the scissors in two pieces.As the component broke during use and no sample was returned, medline was unable to determine the responsible party; this complaint has been provided to the component manufacturing facility for further evaluation, and the division will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: TRAY,SUTURE REMOVAL,MTL IRIS&ADSON FCP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854338
• Report Number: 1417592-2026-47490
• Device Sequence Number: 9553432
• Product Code: LRO
• UDI-Device Identifier: 10080196039654
• UDI-Public: 10080196039654
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Catalogue Number: DYNJ07254AH
• Device Lot Number: 25CBU131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown