MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAMINECTOMY PACK

Catalog Number	DYNJ41443T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i have had 3 reports so far about surgical blades falling off of knife handles.1 was today during the initial incision for a back fusion and the other 2 were during total joints.".
Additional Manufacturer Narrative
The account reported finding blade falls out of knife handle, and the complaint text reported surgical blades falling off of knife handles during the initial incision for a back fusion and during total joints.No sample or photo was received for the investigation; finished good production records were unable to be reviewed as no lot number was provided, the finished good pack build was reviewed and no issues were identified that would likely contribute to the reported concern, and trending was reviewed.Medline was unable to confirm the defect as no samples or detailed photos were provided, and without a sample, it is challenging to determine the true root cause of the reported issue.Our supplier quality team will monitor this issue for trending purposes, and no medical intervention, serious injury, or follow-up care has been reported.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-LAMINECTOMY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870156
• Report Number: 1417592-2026-49010
• Device Sequence Number: 9314621
• Product Code: OJH
• UDI-Device Identifier: 10198459156571
• UDI-Public: 10198459156571
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/22/2026

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: DYNJ41443T
• Device Lot Number: UNK MXC
• 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: 02/10/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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