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

Catalog Number	DYNJ87215A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we received this pack opened in the case this morning.".
Additional Manufacturer Narrative
The account reported finding open vendor seal.A photo was received for the investigation; the affected pack was depicted in the photo, the white tyvek was completely open and had been opened along its sealed section as if opened normally, finished good production records and finished good pack build were reviewed, and a stock check was issued for the pack and component with no affected stock found for either.Based on the review of the photos provided, medline confirmed that the tyvek seal had completely opened.Medline receives this item pre-sealed from the component supplier, and review of component inventory and inspection records did not find any similar issues; based on that, it is likely that the open seal occurred after the pack left the kitting facility at some point during transit or storage, and the supplier quality team 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 PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754855
• Report Number: 1417592-2026-39307
• Device Sequence Number: 21240439
• Product Code: OJH
• UDI-Device Identifier: 40198459135997
• UDI-Public: 40198459135997
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: DYNJ87215A
• Device Lot Number: 24JBW184
• 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: 12/20/2024
• Initial Report FDA Received Date: 09/14/2026
• 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