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

Catalog Number	DYNJ69338A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer received this product unsealed and unable to use.".
Additional Manufacturer Narrative
The account reported finding the breather pouch open.The investigation included a stock check, review of finished good production records, review of finished good pack build, trending review, and sample evaluation; the stock check found no defects, and the sample evaluation found the lower part of the tyvek portion was fully open.The reported problem was confirmed by the sample evaluation.The tyvek cover appeared wrinkled and tugged, indicating it is likely that the pack was mishandled and opened at some point after assembly; with the information provided, medline was not able to confirm at what point the damage occurred.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 JOINT PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755808
• Report Number: 1417592-2026-39470
• Device Sequence Number: 9361643
• Product Code: OJH
• UDI-Device Identifier: 40195327171330
• UDI-Public: 40195327171330
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/09/2026

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: DYNJ69338A
• Device Lot Number: 23LBH364
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2024
• 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: 02/21/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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