MAUDE Adverse Event Report: Medline Industries, LP CENTURION; WIRE CUTTER, STERILE (WCS144)

Catalog Number	66240
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the wire cutters we bought don¿t cut the wires.".
Additional Manufacturer Narrative
The account reported that the wire cutters they ordered do not cut any wires they tried it on; the issue did not occur during use and no injury was reported.No sample or photo was received for the investigation; finished good production records were reviewed, finished good pack build was reviewed, and trending was reviewed with 0 additional reported complaints for this issue for the account and component in the past 24 months.At this time, medline is unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation; the cause code was unconfirmed defect with sample required to determine cause.The division will monitor this issue for trending purposes, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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: CENTURION
• Common Device Name: WIRE CUTTER, STERILE (WCS144)
• Manufacturer (Section D): Medline Industries, LP; 301 catrell drive; howell MI 48843
• Manufacturer Contact: urmi parekh ; 301 catrell drive; howell, MI 48843
• MDR Report Key: 50806583
• Report Number: 1824619-2026-00072
• Device Sequence Number: 10575543
• Product Code: JOK
• UDI-Device Identifier: 00653160008791
• UDI-Public: 00653160008791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 66240
• Device Lot Number: 25DBA300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown