MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 6.0MM CARBIDE ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820110060C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke in the attachment.It was also reported there were no delays 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 bur broke due to issues with the associated elite 7cm straight attachment (5407120450 s/n(b)(4)).The proximal bearing is likely to have been failing resulting in the bur to break at the notch.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke in the attachment.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 6.0MM CARBIDE ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8351741
• Report Number: 0001811755-2019-00587
• Device Sequence Number: 14010450
• Product Code: HBE
• UDI-Device Identifier: 07613327294972
• UDI-Public: 07613327294972
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/19/2019

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: No Information
• Device Catalogue Number: 5820110060C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5407120450, S/N: (B)(4)