MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5820103015

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation if the device is available.

Event Description

It was reported that during a cranial procedure, the bur overheated, leaving a black trace on the bone flap.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

H2: correction to state device not returned.H2: additional information to add associated device.H6: the quality investigation is complete.H3 other text : device not returned.

Event Description

It was reported that during a cranial procedure, the bur overheated, leaving a black trace on the bone flap.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: 1.5MM WIRE PASS DRILL BIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18756636
• MDR Text Key: 335943759
• Report Number: 3015967359-2024-00410
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 04546540362421
• UDI-Public: 04546540362421
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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 Operator: Health Professional
• Device Catalogue Number: 5820103015
• Device Lot Number: 23233017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5407120450- S/N: (B)(6). ; 5407300000, PI DRIVE PLUS MOTOR, S/N: (B)(6).