MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SOI SHOULDER

Catalog Number	DYNJ02213N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "we had a shoulder pack with #10 blade in a package that was not a complete blade.".
Additional Manufacturer Narrative
The account reported finding broken blade in packaging.A photo was received for the investigation and no physical sample was available; two photos of a blade outside of vendor packaging were reviewed, there was no apparent damage to the outside of the vendor packaging, and the blade next to the vendor packaging was incomplete with the small metal piece along the bottom of the blade connecting the back to the tip not present.The vendor reviewed the photo provided and confirmed the reported issue, but no root cause could be identified; medline's investigation considered the root cause to be a vendor product issue relating to the component manufacturing process.This 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: SOI SHOULDER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886605
• Report Number: 1417592-2026-50350
• Device Sequence Number: 9827161
• Product Code: OJH
• UDI-Device Identifier: 10195327535377
• UDI-Public: 10195327535377
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/23/2026

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: DYNJ02213N
• Device Lot Number: 24LMG231
• Was Device Available for Evaluation?: No
• 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: 04/07/2025
• Initial Report FDA Received Date: 09/24/2026
• 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