MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SHOULDER ARTHRO PACK

Catalog Number	DYNJ48941D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our current shoulder packs have all broken 18g spinal needles.The stylet will not remove from the needle.".
Additional Manufacturer Narrative
The account reported the current shoulder packs have all broken 18g spinal needles and the stylet will not remove from the needle.No sample or photo was received for the investigation; the packs production record could not be reviewed due to the absence of a lot number, and a review of the pack build was completed with no issues identified that contributed to the reported issue.Based on the investigation, medline was unable to confirm the reported issue as the spinal needle was not provided at this time.Regarding the spinal needle, the root cause for the spinal needle concern has been determined to be due to reduced clearance between the outer and inner needles, resulting from dimensional tolerances and rough inner needle surfaces; 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-SHOULDER ARTHRO PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50754708
• Report Number: 1417592-2026-39274
• Device Sequence Number: 9241566
• Product Code: OJH
• UDI-Device Identifier: 10198459398278
• UDI-Public: 10198459398278
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: DYNJ48941D
• 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: 03/16/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown