MAUDE Adverse Event Report: SMITH NEPHEW, INC.; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO

Model Number 210439

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

Smith and nephew drill bit 2.0 used on operative field broke while in use.Device removed from field.No harm to the patient.

• Brand Name: NA
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15814756
• MDR Text Key: 303834689
• Report Number: 15814756
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 03596010102560
• UDI-Public: (01)03596010102560
• 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: 11/03/2022

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 Model Number: 210439
• Device Catalogue Number: 210439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female