MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; KNEE ARTHROSCOPY III-LF

Catalog Number	DYNJS0810
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, there was moisture and residue inside the syringe.
Additional Manufacturer Narrative
According to the facility, there was moisture and residue inside the syringe.Per the facility, "the moisture was noticed as soon as the knee pack was opened so this syringe was not used in the case and set aside right away.There was no patient contact at all." no additional information at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for (b)(6) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Updated h3: device evaluated by manufacturer, updated h6: investigation findings (c), updated h6: investigation conclusions (d).

• Brand Name: MEDLINE
• Common Device Name: KNEE ARTHROSCOPY III-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093-2753 ; 2173279112
• MDR Report Key: 24433304
• Report Number: 1423395-2026-00026
• Device Sequence Number: 10303553
• Product Code: OJH
• UDI-Device Identifier: 10080196934720
• UDI-Public: 10080196934720
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJS0810
• Device Lot Number: 25KBK794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown