MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM NEURO (MATCH HEAD); DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820107440
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, that inner pack of the bur was sealed with the outer pack and bur would not drop down into the sterile field.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, that inner pack of the bur was sealed with the outer pack and bur would not drop down into the sterile field.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, that inner pack of the bur was sealed with the outer pack and bur would not drop down into the sterile field.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.

• Brand Name: 4.0MM NEURO (MATCH HEAD)
• Common Device Name: 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 13569886
• Report Number: 3015967359-2022-00373
• Device Sequence Number: 17620464
• Product Code: HBE
• UDI-Device Identifier: 07613153022671
• UDI-Public: 07613153022671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: 5820107440
• Device Catalogue Number: 5820107440
• Device Lot Number: 21221017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown