MAUDE Adverse Event Report: LIFE INSTRUMENT CORP. 2MM KERRISON RONGEUR

Model Number 830-0802-0

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2023

Event Type  Injury  

Event Description

Kerrison broke while using to the patient during surgery, all pieces were obtained.

• Brand Name: 2MM KERRISON RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): LIFE INSTRUMENT CORP.; braintree MA 02184
• MDR Report Key: 18410113
• MDR Text Key: 331610487
• Report Number: MW5149630
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 830-0802-0
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 57 KG