MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM MULTI-FLUTE ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820110020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that the bur broke at the neck during a lumbar fusion.It was further reported that the a piece of the bur had to be removed from the patient's bone.It was also reported that there was a 10 to 20 minute delay and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that the most likely cause of breakage is metal contact along with lack of or insufficient irrigation during use.The quality investigation is complete.
Event or Problem Description
It was reported that the bur broke at the neck during a lumbar fusion.It was further reported that the a piece of the bur had to be removed from the patient's bone.It was also reported that there was a 10 to 20 minute delay and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 2.0MM MULTI-FLUTE ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8775389
• Report Number: 0001811755-2019-02243
• Device Sequence Number: 1978075
• Product Code: HBE
• UDI-Device Identifier: 07613327294699
• UDI-Public: 07613327294699
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 5820110020
• Device Lot Number: 19093017/19094017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention