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

Catalog Number	DYNJ04059
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the prongs went under the staple, but the top prong would not catch the staple to remove.
Additional Manufacturer Narrative
The customer reported that during use, a 2-week total knee replacement patient was in for 1st post-op appointment and needed staples removed; when the staple remover was opened and used to remove the first staple, the prongs went under the staple, but the top prong would not catch the staple to remove, and the patient stated it was uncomfortable.No sample or photo received for the investigation; the pack and production records were reviewed, there were no line-down situations, no run without approvals, deviations or non-conformance reports that might have had an impact on this issue, and trending was reviewed.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 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: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858317
• Report Number: 1417592-2026-48098
• Device Sequence Number: 9497840
• Product Code: FSM
• UDI-Device Identifier: 10884389398487
• UDI-Public: 10884389398487
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/22/2026

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: DYNJ04059
• Device Lot Number: 25FBV577
• Was Device Available for Evaluation?: No
• 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: 12/08/2025
• 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