MAUDE Adverse Event Report: LIFE INSTRUMENT CORP. KERRISON RONGUER 3MM

Model Number 830-0803-0

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2022

Event Type  Injury  

Event Description

A 3mm kerrison rongeur in use, screw began to back out of kerrison rongeur and pieces came apart.All pieces retrieved.Kerrison rongeur removed from the sterile field and replaced.Fda safety report id# (b)(4).

• Brand Name: KERRISON RONGUER 3MM
• Type of Device: RONGUER
• Manufacturer (Section D): LIFE INSTRUMENT CORP.; braintree MA
• MDR Report Key: 14014952
• MDR Text Key: 288679263
• Report Number: MW5108758
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 830-0803-0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White