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

Model Number	8450009030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the device overheated and 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.This record addresses the instance of the bur breaking.
Additional Manufacturer Narrative
H6; 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.The quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the device overheated and 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.This record addresses the instance of the bur breaking.

• 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: 9745669
• Report Number: 0001811755-2020-00545
• Device Sequence Number: 714176
• Product Code: HBE
• UDI-Device Identifier: 07613327096804
• UDI-Public: 07613327096804
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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 Model Number: 8450009030
• Device Catalogue Number: 8450009030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1