MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM SPIRAL ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number 5407FA1015SP

Device Problems Break (1069); Fracture (1260)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The quality investigation is complete.Awaiting return of device to manufacturer.

Event Description

It was reported that during a surgical procedure, the bur broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a surgical procedure, the bur broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 1.5MM SPIRAL ROUTER
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11807256
• MDR Text Key: 250371580
• Report Number: 3015967359-2021-00835
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 07613327096705
• UDI-Public: 07613327096705
• Combination Product (y/n): N
• PMA/PMN Number: K143399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 5407FA1015SP
• Device Catalogue Number: 5407FA1015SP
• Device Lot Number: 20083027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1