MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.0MM NEURO (MATCH HEAD) SOFT TOUCH; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820107020
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during a surgical procedure, the tip of the bur broke.It was also reported that there was a 10 to 15 minute delay as a result of this event to locate and remove the broken fragment.It was further reported that there were no adverse consequences as a result of this event 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, the tip of the bur broke.It was also reported that there was a 10 to 15 minute delay as a result of this event to locate and remove the broken fragment.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: 2.0MM NEURO (MATCH HEAD) SOFT TOUCH
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11339748
• Report Number: 3015967359-2021-00006
• Device Sequence Number: 883358
• Product Code: HBE
• UDI-Device Identifier: 04546540362469
• UDI-Public: 04546540362469
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 02/01/2023
• Device Model Number: 5820107020
• Device Catalogue Number: 5820107020
• Device Lot Number: 20049017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1