MAUDE Adverse Event Report: STRYKER STRYKER DRILLS, BURRS, TREPHINES AND ACCESSORIES

Model Number 5407-120-970C

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/06/2017

Event Type  malfunction  

Event Description

Patient undergoing laminectomy when the drill attachment unexpectedly became hot and caused a burn to the skin adjacent to the lumbar incision.

• Brand Name: STRYKER
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES
• Manufacturer (Section D): STRYKER
• MDR Report Key: 6950923
• MDR Text Key: 89616365
• Report Number: MW5072752
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 5407-120-970C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 10/13/2017 Patient Sequence Number: 1