MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS 3.0 DRILL BIT; BIT, DRILL

Model Number 45-30005

Device Problems Break (1069); Dull, Blunt (2407); Mechanics Altered (2984)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

During the procedure, the drill broke with the kwire inside.Unable to release kwire from drill bit.Per doctor, this event has happened in the past.Upon checking the equipment after, the surgical technologist (st) noticed that the drill looked dull.The surgical item was sequestered and given to clinical educator to follow up with the vendor from stryker.

• Brand Name: 3.0 DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS; 325 corporate dr.; mahwah NJ 07430
• MDR Report Key: 16617763
• MDR Text Key: 312027503
• Report Number: 16617763
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-30005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2023
• Date Report to Manufacturer: 03/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA