MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STAPLER 35 WIDE

Catalog Number	STAPLER35WPB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "staples are breaking in half with during use.".
Additional Manufacturer Narrative
According to the customer the staples were "breaking in half" during use; the customer reported there were "no issues related to this concern" in regards to the patient¿s status and no serious injury, medical intervention, or follow-up care related to the reported incident.No sample or photo was received for the investigation; finished good production records were reviewed with no line down situations, no run without approvals, deviations, or non-conformance reports, and the bom and picklist were reviewed with all correct components and quantities added according to specifications.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided, and the cause was documented as sample required to determine cause.There has been no change to the reportability decision associated with this complaint, 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: MEDLINE
• Common Device Name: STAPLER 35 WIDE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896164
• Report Number: 1417592-2026-50696
• Device Sequence Number: 14910131
• Product Code: QQS
• UDI-Device Identifier: 10884389030844
• UDI-Public: 10884389030844
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/25/2026

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: STAPLER35WPB
• Device Lot Number: 25GBF372
• 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: 10/17/2025
• Initial Report FDA Received Date: 09/25/2026
• 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 Age: 42 YR
• Patient Sex: Female