MAUDE Adverse Event Report: MEDTRONIC INC. EXTENSION 8 ASSEMBLY; BIT, DRILL

Model Number EX103128

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

One crucial piece of screwdriver for screw removal was missing inside the os spine screw removal set -hs48001n.This element ref.(b)(4) -extension 8 assy, allows to provide a correct working length between the handle and the differents screws removal tips.Without this is impossible to the surgeon to operate inside the corpse of the patient.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EXTENSION 8 ASSEMBLY
• Type of Device: BIT, DRILL
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 17535219
• MDR Text Key: 321451876
• Report Number: MW5142118
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: EX103128
• Patient Sequence Number: 1