MAUDE Adverse Event Report: ETHICON, INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B405

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

During a robotic procedure the needle popped off a suture prior to use in the patient's cavity.The item was replaced with another suture with the same lot number with no complications.The patient was not affected.Fda safety report id # (b)(4).

• Brand Name: STRATAFIX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 15916627
• MDR Text Key: 304920605
• Report Number: MW5113628
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: SXPP1B405
• Device Catalogue Number: SXPP1B405
• Device Lot Number: RLBEDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose