MAUDE Adverse Event Report: Medline Industries, LP CENTURION; LITTAUER NAIL NIPPER

Catalog Number	I68160
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "jaws did not line up and they were dull.".
Additional Manufacturer Narrative
The account reported finding defective and dull nippers.A photo was received for the investigation, the photos showed the nail nipper, component nn32185, with misaligned tips, finished good production records found no nonconformances, and the bill of materials was reviewed with no issues identified.The customer's report of misalignment is confirmed; the report of dullness of the instrument is unable to be confirmed without return of the sample.The cause was documented as supplier error/mishandling by manufacturing or can't determine for the defective issue, and sample required to determine cause for the dull issue; the component manufacturing facility was notified 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: CENTURION
• Common Device Name: LITTAUER NAIL NIPPER
• 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: 50806966
• Report Number: 1824619-2026-00073
• Device Sequence Number: 20981685
• Product Code: KDC
• UDI-Device Identifier: 10653160258421
• UDI-Public: 10653160258421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/17/2026

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: I68160
• Device Lot Number: 2025042801
• 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: 07/07/2025
• 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