MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC. KERRISON RONGEUR 3MM

Model Number 57-0763

Device Problem Break (1069)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

A 3mm kerrison rongeur broke while in normal use.A pin that holds the open/close mechanism in place came out which prevented use.Surgeon stated that it was not working, passed it to scrub nurse.All pieces immediately secured and removed from the sterile.Fda safety report id# (b)(4).

• Brand Name: KERRISON RONGEUR 3MM
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL, INC.
• MDR Report Key: 15543466
• MDR Text Key: 301279265
• Report Number: MW5112429
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57-0763
• Device Catalogue Number: 57-0763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: READER
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White