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

Catalog Number	DYNJ04058
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "staff are reporting the medline have a very loose joint and causes the staple to slip around not allowing a nice pinch to remove the staple.The staples are bending weird causing increased pain to the patients.Bending weird can cause the staples to go into the skin or a difficult removal.".
Additional Manufacturer Narrative
The customer reported the staple remover "would twist the staple causing removal to be challenging" and that staple removal was initially more painful.No sample or photo received for the investigation; finished good production records were reviewed, finished good pack build was reviewed, and trending was reviewed with 0 additional reported complaints for this issue for the account and component in the past 6 months.With the information provided, medline was not able to confirm at what point the damage occurred or what may have caused it; the reported event is unconfirmed and sample required to determine cause.No injury or additional medical intervention was required, no follow-up care has been reported, and supplier quality team 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: DBD-REMOVER,STAPLE,SKIN,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818330
• Report Number: 1417592-2026-44608
• Device Sequence Number: 15996700
• Product Code: GDT
• UDI-Device Identifier: 40080196846925
• UDI-Public: 40080196846925
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: DYNJ04058
• Device Lot Number: 22KBG377
• 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: 07/12/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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