MAUDE Adverse Event Report: STRYKER INSTRUMENTS RADIOLUCENT DRILL BIT; BIT, SURGICAL

Model Number 4200-355-040

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/25/2020

Event Type  malfunction  

Event Description

When drilling the distal femoral screw for long tfn, the screw broke off in the patient.Doctor determined it was safer for the patient to leave in then to try retrieve.Additional information received from the reporter on 1/6/2021 to change the manufacturer from synthes to stryker.Fda safety report id# (b)(4).

• Brand Name: RADIOLUCENT DRILL BIT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; kalamazoo MI 49001
• MDR Report Key: 11131509
• MDR Text Key: 225779772
• Report Number: MW5098707
• Device Sequence Number: 1
• Product Code: GFG
• 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: 01/04/2021

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: 4200-355-040
• Device Lot Number: 20043017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2021
• 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 Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 24