MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT MEDLINE; SHOULDER ARTHROSCOPY

Catalog Number	DYNJ901312K
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blades in the custom packs are dull.
Additional Manufacturer Narrative
It was reported that the blades in the custom packs are dull.There were no reports of death, serious injury, medical intervention, or follow up care.

• Brand Name: MEDLINE
• Common Device Name: SHOULDER ARTHROSCOPY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 6757
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24931319
• Report Number: 1423395-2026-00099
• Device Sequence Number: 10651757
• Product Code: OJH
• UDI-Device Identifier: 10198459279775
• UDI-Public: 10198459279775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: DYNJ901312K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/25/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown