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

Catalog Number	DYNJ05059
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staples break in half.They are flimsy.
Additional Manufacturer Narrative
According to the customer, the staple removers are "extremely difficult to get the blades underneath the staple without puncturing the skin or causing the patient discomfort" and "sometimes cut the staple in half during removal"; when the staple is cut in half they have to "manually pull out the other half of the staple," and "no patient harm has occurred." a sample was received; the account returned one case of unused stapler remover packs, three packs were open with no visual defects noted, and for functional testing, staplers were removed from a skin pad, and no issues were noted.Medline was unable to confirm the reported issue with the sample received, and no visual defects or functional defects were noted; cause was not confirmed with received sample.Trending was reviewed and there have been 0 additional reported complaints for this issue for the account and component in the past 6 months, and the division will monitor 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: STAPLE REMOVER TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946404
• Report Number: 1417592-2026-54248
• Device Sequence Number: 9624007
• Product Code: GAG
• UDI-Device Identifier: 40888277932518
• UDI-Public: 40888277932518
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: DYNJ05059
• Device Lot Number: 24CBE361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2024
• 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: 04/25/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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