MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CHS TOTAL JOINT PACK II

Catalog Number	DYNJCH916
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that these two packs were not sealed correctly.
Additional Manufacturer Narrative
The account reported finding open seal in the chs total joint pack ii.Medline issued a call tag; no sample or photo was received for the investigation, stock was checked with no affected stock found, the pack production record was reviewed with no line down situations, deviations, run-withouts, or non-conformance reports, and the bill of materials was reviewed.Based on the complaint details, medline was unable to determine which seal was affected due to no sample or photo being provided; the root cause was unconfirmed/sample required to determine cause.The complaint was provided to the vendor for further evaluation, 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: CHS TOTAL JOINT PACK II
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50714435
• Report Number: 1417592-2026-35703
• Device Sequence Number: 10585983
• Product Code: OJH
• UDI-Device Identifier: 40193489889117
• UDI-Public: 40193489889117
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/05/2026

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: DYNJCH916
• Device Lot Number: 23HBT525
• 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: 12/21/2023
• Initial Report FDA Received Date: 09/10/2026
• 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