MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-ALIF PACK

Catalog Number	DYNJ69668B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "a #15 surgical blade broke while in use during our alif procedure.The blade was retrieved from disc space (the broke side) and the sterile field as soon as this was noticed.This blade came from our alfi pack." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that "a #15 surgical blade broke while in use during our alif procedure.The blade was retrieved from disc space (the broke side) and the sterile field as soon as this was noticed.This blade came from our alfi pack.".

• Brand Name: MEDLINE
• Common Device Name: DBD-ALIF PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 1170 s northpoint boulevard; waukegan 60085 6757
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24533942
• Report Number: 1423395-2026-00039
• Device Sequence Number: 9027006
• Product Code: LRO
• UDI-Device Identifier: 10195327674960
• UDI-Public: 10195327674960
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ69668B
• Device Lot Number: 25LLA515
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown