MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DBD-TOTAL KNEE-LF

Model Number	DYNJVB91048A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, a suture needle in a total knee pack broke during surgery.It was further reported a second incident occurred within the past two weeks that had not been reported until 6/23/2021, involving the same pack (1vicryl ctx (j371h).Email received from lead surgical tech, va hospital milwaukee, wisconsin who provided this statement, "we are investigating these incidents here at our facility and we do not believe it is necessary to continue investigating on your end." due diligence has been completed.The exact date of both reported incidents are unknown however, will be documented as 6/1/2021.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No samples will be returned which will make determining a root cause difficult if not impossible.Due to the reported incident and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, a suture needle in a total knee pack broke during surgery.It was further reported a second incident occurred within the past two weeks that had not been reported until 6/23/2021, involving the same pack (1vicryl ctx (j371h).

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DBD-TOTAL KNEE-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12129095
• Report Number: 1423395-2021-00030
• Device Sequence Number: 17235844
• Product Code: OJH
• UDI-Device Identifier: 10193489499254
• UDI-Public: 10193489499254
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: DYNJVB91048A
• Device Catalogue Number: DYNJVB91048A
• Device Lot Number: 21EDB446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/07/2021
• 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