MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TOTAL KNEE PACK

Catalog Number	DYNJ65602A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 "lint" was noted on the "sterile laps/sponges", "on surgical site", and "floating in air with use" during a procedure.The customer reported after the reported incident occurred wound irrigation was required.The customer reported the procedure was continued utilizing "single packaged lap sponges".The customer reported there were "no complications reported" as a result of the reported issue.The customer reported there was no serious injury, medical intervention, or follow-up care needed related to the reported incident.No additional information is available at this time.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 medwatch is being filed.If any further.
Event or Problem Description
According to the customer, on (b)(6) 2024 "lint" was noted on the "sterile laps/sponges", "on surgical site", and "floating in air with use" during a procedure.

• Common Device Name: TOTAL KNEE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19536722
• Report Number: 1423395-2024-00430
• Device Sequence Number: 6425381
• Product Code: OJH
• UDI-Device Identifier: 40195327048663
• UDI-Public: 40195327048663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ65602A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/14/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown