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

Catalog Number	5820110020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that the bur broke at the shaft during a lumbar fusion.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully using a new bur.
Additional Manufacturer Narrative
Updated manufacturing date and expiry date upon receipt of lot number.Device evaluation: investigation results indicate that the bur breakage is as a result of metal contact causing localized wear which weakened the neck of the bur.The quality investigation is complete.
Event or Problem Description
It was reported that the bur broke at the shaft during a lumbar fusion.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully using a new bur.

• 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: 8915453
• Report Number: 0001811755-2019-02761
• Device Sequence Number: 2753190
• 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): 10/31/2019

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: 06/01/2022
• Device Catalogue Number: 5820110020
• Device Lot Number: 19170017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1