MAUDE Adverse Event Report: LIFE INSTRUMENT CORPORATION LIFE INSTRUMENTS; RONGEUR

Model Number 837-0904-0

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

While the doctor was using a kerrison 4, the screw that articulates jaws came loose and fell out of the screw hole.Screw was immediately found rolling on or floor.Screw and kerrison showed to pod leader, taken out of service and to be placed in sunmed cabinet at the end of the case.

• Brand Name: LIFE INSTRUMENTS
• Type of Device: RONGEUR
• Manufacturer (Section D): LIFE INSTRUMENT CORPORATION; 91 french ave; braintree MA 02184
• MDR Report Key: 13042805
• MDR Text Key: 282505654
• Report Number: 13042805
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/03/2021,12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 837-0904-0
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male