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

Catalog Number	DYNJ901751R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the #10 blades in the total hip pack have been breaking.".
Additional Manufacturer Narrative
The facility reported that the #10 blades have been breaking, requiring the team to take extra time to search for the missing fragment and an x-ray if the fragment is not retrieved; no fragment retention occurred, and no medical intervention, serious injury, or follow-up care has been reported.The investigation noted that no sample or photo was received, finished good production records were reviewed with no line down situations, deviations, run-without, or non-conformance reports identified, and the finished good pack build was reviewed with no issues noted with placement of the blades that could contribute to the reported issue.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation.The cause was documented as sample required to determine cause, and the division will monitor this issue for trending purposes.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 HIP-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50829200
• Report Number: 1417592-2026-45557
• Device Sequence Number: 10590051
• Product Code: OJH
• UDI-Device Identifier: 10198459107573
• UDI-Public: 10198459107573
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/17/2026

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: DYNJ901751R
• Device Lot Number: 25GDA475
• 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: 10/28/2025
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown