MAUDE Adverse Event Report: BOSS INSTRUMENTS, LTD. BOSS KERRISON RONGEUR, MICRO

Model Number 70-0332P

Device Problems Break (1069); Component Missing (2306); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2020

Event Type  malfunction  

Event Description

Stealth kerrison product broke apart when going to be used initially in case.Found that a screw missing from device.Patient x-ray complete and screw not located.Believed to have fallen out during processing.Fda safety report id# (b)(4).

• Brand Name: BOSS KERRISON RONGEUR, MICRO
• Type of Device: RONGEUR
• Manufacturer (Section D): BOSS INSTRUMENTS, LTD.
• MDR Report Key: 10074903
• MDR Text Key: 191811476
• Report Number: MW5094580
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2020

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: 70-0332P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 95