MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI MEDLINE; DBD-TOTAL KNEE

Catalog Number	DYNJ910373
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
That the pulsavac in the total knee is that the pulsavac in the total knee is defective and would not work.
Additional Manufacturer Narrative
It was reported that the that the pulsavac in the total knee is defective and would not work.There were no reports of death, serious injury, medical intervention, or follow up care.

• Brand Name: MEDLINE
• Common Device Name: DBD-TOTAL KNEE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI; calle circuito del desierto #7; parque industrial del desierto; mexicali, baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25032006
• Report Number: 1423395-2026-00078
• Device Sequence Number: 13293570
• Product Code: OJH
• UDI-Device Identifier: 10195327654740
• UDI-Public: 10195327654740
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/29/2026

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: DYNJ910373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/29/2026
• 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