MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SHOULDER SPLIT I-LF

Catalog Number	DYNJS0840
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that no defect was described in the complaint text.
Event or Problem Description
It was reported that there was a dirty piece of plastic/tape on the inside of the pack.
Additional Manufacturer Narrative
The complaint text states "material description: shoulder split i-lf" and "material number: (b)(6)"; no reported failure was described.The investigation is listed as "none" and the record states "no attachment documents available." the record does not state that the reported problem was confirmed or not confirmed, and no root cause was identified.No defect facts are available in the provided complaint or investigation text.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.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to document a correction resulting from a duplicate complaint review.Upon further review, it was determined that the event described in this mdr is a duplicate of patient identifier 200703599 and does not represent a separate reportable event.The original complaint was entered in error as a unique complaint when it should have been associated with the previously reported event.Therefore, this report should not be considered a separate mdr reportable event.This supplemental submission is being made to correct the regulatory record and maintain accurate complaint and mdr documentation.There is no change to the reported event, device evaluation, investigation findings, or conclusions associated with the original reportable event under patient identifier 200703599.

• Brand Name: MEDLINE
• Common Device Name: SHOULDER SPLIT I-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: 50802894
• Report Number: 1417592-2026-43377
• Device Sequence Number: 8653013
• Product Code: OJH
• UDI-Device Identifier: 10080196934706
• UDI-Public: 10080196934706
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: DYNJS0840
• Device Lot Number: 25IMB753
• 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: 12/19/2025
• Initial Report FDA Received Date: 09/17/2026
• 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