MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-AMB KNEE ARTHROSCOPY

Catalog Number	DYNJ59928C
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "dull no.15 blades.".
Additional Manufacturer Narrative
The account reported finding a dull blade in the knee arthroscopy pack; the complaint transcript noted dull blades and an update that the item should be no 11 blade.Medline received no sample or photo for the investigation, production records were unable to be reviewed as no lot number was provided, and a review of the finished good pack build found no issues with the build that likely contributed to the reported issue.Without a sample or detailed pictures, medline was unable to confirm the reported defect, and the cause code was "sample required to determine cause." the vendor response stated that dull condition blades are related to the inherent process variability during the grinding process and that initial adjustments and/or stropper units misalignment could be a factor; defect continues to be monitored and the incident was found to be acceptable.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-AMB KNEE ARTHROSCOPY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50221791
• Report Number: 1417592-2026-15850
• Device Sequence Number: 10436749
• Product Code: LRO
• UDI-Device Identifier: 40195327037063
• UDI-Public: 40195327037063
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/12/2026

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: DYNJ59928C
• Device Lot Number: UNK PDM
• 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: 06/19/2023
• Initial Report FDA Received Date: 08/12/2026
• 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