MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LAP,PUSHER,KNOT,OPEN END,4MM,35CM

Catalog Number MDS522307AC

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 "silk braided suture frayed as the knot pusher was used on the suture".Due to this, all sutures had to be removed and replaced.The customer reported this added 15 minutes to the procedure and anesthesia time.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Knot pusher caused silk braided suture to fray.

Manufacturer Narrative

Updated codes to include investigation findings.

• Type of Device: LAP,PUSHER,KNOT,OPEN END,4MM,35CM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17441950
• MDR Text Key: 320222031
• Report Number: 1417592-2023-00323
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

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
• Device Catalogue Number: MDS522307AC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other