MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SKIN STAPLE REMOVER

Catalog Number	DYNJ04058A
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the problem is that the new item when the nurse/doctor have tried to remove the staple it locks and is a patient safety.".
Additional Manufacturer Narrative
The customer reported that during patient use, when the nurse/doctor tried to remove the staple, the new item locks, and according to the facility the staple remover closed and would not open again and the device "broke in half"; the same thing occurred with a second staple remover.A photo was received for the investigation, finished good production records were reviewed, finished good pack build was reviewed, and trending was reviewed.Per the photos provided, the photos do not show the component defect or component clearly and the reported issue could not be confirmed.At this time, the reported defect was unable to be confirmed, as no physical sample or detailed photographic evidence was provided to support the investigation; 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: SKIN STAPLE REMOVER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50756905
• Report Number: 1417592-2026-39623
• Device Sequence Number: 21249681
• Product Code: KDC
• UDI-Device Identifier: 10653160385769
• UDI-Public: 10653160385769
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/08/2026

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: DYNJ04058A
• Device Lot Number: 2025032090
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/14/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown