MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM NEURO (MATCH HEAD) LESS AGGRESSIVE; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5820107430S1

Device Problems Fracture (1260); Temperature Problem (3022)

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

Event Date 07/28/2023

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 surgical procedure, the bur broke in the attachment.It was further reported that the device overheated.It was also reported there were no adverse consequences as a result of this event.It was further reported that there was a short delay to obtain an alternative device and the procedure was completed successfully.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text : device not returned.

Event Description

It was reported that during a surgical procedure, the bur broke in the attachment.It was further reported that the device overheated.It was also reported there were no adverse consequences as a result of this event.It was further reported that there was a short delay to obtain an alternative device and the procedure was completed successfully.

• Brand Name: 3.0MM NEURO (MATCH HEAD) LESS AGGRESSIVE
• 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: 17631053
• MDR Text Key: 322040622
• Report Number: 3015967359-2023-01904
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5820107430S1
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 5407120900 S/N: (B)(6)