MAUDE Adverse Event Report: BOSS INSTRUMENTS, LTD KERRISON; RONGEUR

Model Number REF#70-0370

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Doctor was using a 5mm kerrison intra op; the screw fell out of the instrument and into the wound.The screw was found and removed from the wound.The instrument and screw were removed from the sterile field and given to materials coordinator.X-ray was taken, and read as negative by radiology.Doctor aware of the x-ray results.No harm to the patient.

• Brand Name: KERRISON
• Type of Device: RONGEUR
• Manufacturer (Section D): BOSS INSTRUMENTS, LTD; 104 sommerfield drive; gordonsville VA 22942
• MDR Report Key: 4683369
• MDR Text Key: 16562642
• Report Number: 4683369
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: REF#70-0370
• Device Catalogue Number: 70-0370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2015
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 68