MAUDE Adverse Event Report: STRYKER CORPORATION PI DRILL; DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Shortly after procedure started, the surgeon noted that the drill handpiece was warm.They requested that it be removed from the field and replaced with a new drill.Manufacturer response for pi drill, stryker (per site reporter): unknown.

• Brand Name: PI DRILL
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 12480733
• MDR Text Key: 271752745
• Report Number: 12480733
• Device Sequence Number: 1
• Product Code: HBE
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24090 DA
• Patient Weight: 99