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

Model Number 57-0763

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

Event Date 03/20/2024

Event Type  Injury  

Event Description

Kerrison rongeur broke while in use, a pin that holds together multiple pieces came out.All pieces retrieved.

• Brand Name: SYMMETRY SURGICAL 3MM KERRISON
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; antioch TN 37013
• MDR Report Key: 18991213
• MDR Text Key: 338891484
• Report Number: MW5153291
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 130 KG