MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; MOORESVILLE TOTAL KNEE PAC

Model Number	DYNJ64730
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no contact information to follow up with the customer.According to the facility, the reported sponges are shredding very easily and leaving strings in the wound.It was reported there were no injuries regarding the reported incident.No follow-up care reported, related to the event.Due to the reported need for medical intervention, and in an abundance of caution, this is a mdr reportable event.The sample was returned for evaluation.Inspection of the used sample concluded, the manufacturer was unable to determine if the extra strings were attached or detached from the weave of the laps, there appears to be no damage to the received device.If additional information becomes available this report will be re-opened and re-evaluated.
Event or Problem Description
It was reported the sponges were shredding very easily during surgery, leaving strings in the wound.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: MOORESVILLE TOTAL KNEE PAC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10212524
• Report Number: 1423395-2020-00016
• Device Sequence Number: 2108004
• Product Code: OJH
• UDI-Device Identifier: 10193489216448
• UDI-Public: 10193489216448
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ64730
• Device Catalogue Number: DYNJ64730
• Device Lot Number: 20CDB982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention