MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-TOTAL ANTERIOR HIP

Catalog Number	DYNJ910861
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have another spinal needle unsheathed and sticking out of the bowl in the pack (total anterior).".
Additional Manufacturer Narrative
The account reported that the needle was unsheathed inside the pack, and the complaint transcript stated that the issue did not occur during use and no injury occurred.A photo was received for the investigation, finished good production records were reviewed with no non-conformances noted, and the finished good pack build was reviewed.The photo shows the account holding the bowl subassembly, with the spinal needle protruding from the bowl without its sheath, confirming the reported issue.Needles are received by medline with the cap already secured by the vendor and the cap is not manipulated during kit assembly; the root cause was identified as a vendor product issue relating to the component manufacturing process, and the complaint was provided to the component manufacturing facility for further evaluation.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-TOTAL ANTERIOR HIP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50797334
• Report Number: 1417592-2026-43170
• Device Sequence Number: 18773976
• Product Code: OJH
• UDI-Device Identifier: 10198459159954
• UDI-Public: 10198459159954
• 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): 09/15/2026

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: DYNJ910861
• Was Device Available for Evaluation?: No
• 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: 11/20/2025
• Initial Report FDA Received Date: 09/17/2026
• 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