MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM PRECISION ROUND, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450009030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event, for bur breakage, was not confirmed as the bur was not returned for evaluation.Without the bur, the root cause cannot be determined.Device not available for return.
Event or Problem Description
It was reported that during a minimally invasive spine surgical procedure, the bur broke in the attachment.It was also reported there were a 10 minute delay.It was further reported that no adverse consequences occurred as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a minimally invasive spine surgical procedure, the bur broke in the attachment.It was also reported there were a 10 minute delay.It was further reported that no adverse consequences occurred as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.

• Brand Name: 3.0MM PRECISION ROUND, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8395355
• Report Number: 0001811755-2019-00730
• Device Sequence Number: 1436549
• Product Code: HBE
• UDI-Device Identifier: 07613327096804
• UDI-Public: 07613327096804
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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 Catalogue Number: 8450009030
• Device Lot Number: 18065017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: 5407120950C S/N, UNKNOWN; 5407120950C S/N, UNKNOWN