MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PACK ORTHO LOWER EXTREMITY

Catalog Number	DYNJ60120F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the blades have been breaking in half.".
Additional Manufacturer Narrative
The account reported finding blade is breaking in half in the dbd-pack ortho lower extremity.The account provided three photos to aid in the investigation; the first photo depicted the pack insert and the remaining two photos depicted the packaging for blade no.15 ss, with no images received of the broken blade, and the finished good production records and pack build were reviewed with no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue.Based on the complaint details and due to the photos provided within the complaint not depicting the broken blade, the reported concern could not be confirmed at this time; sample required to determine cause.The complaint was provided to the component manufacturing facility for further evaluation, the supplier quality team will monitor this issue for trending purposes, and no corrective actions were implemented at this time.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-PACK ORTHO LOWER EXTREMITY
• 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: 50222481
• Report Number: 1417592-2026-15896
• Device Sequence Number: 21401173
• Product Code: LRO
• UDI-Device Identifier: 40195327372478
• UDI-Public: 40195327372478
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: DYNJ60120F
• Device Lot Number: 24AMH018
• 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: 04/04/2024
• 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