MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,SUTURE REMOVAL,MTL LITT

Catalog Number	MDS708555
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "inconsistent thickness and point on suture end of scissors, have to open multiple packs to find a pair of suture scissors small, thin and pointy enough to removed small sutures.".
Additional Manufacturer Narrative
The account reported finding defective scissors with "inconsistent thickness and point on suture end of scissors." a sample was received for investigation, and the account returned 2 unused packs for review; finished good production records and finished good pack build were reviewed, with no issues identified that likely contributed to the reported issue.Upon opening the package, the difference in scissors noted by the account was confirmed: one scissor had a thinner pointed tip and width overall, while the other sample had a thicker pointed tip.Based on the complaint details the root cause is considered to be a vendor/supplier product issue relating to the component manufacturing process, and the vendor noted the inconsistencies in thickness of the scissor's edge and contributed it to the manual/hand process by which the scissors are made.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 LITT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50817654
• Report Number: 1417592-2026-44527
• Device Sequence Number: 15992038
• Product Code: MCZ
• UDI-Device Identifier: 40080196999041
• UDI-Public: 40080196999041
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/18/2026

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: MDS708555
• Device Lot Number: 23HBM141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/11/2023
• 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: 09/29/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown