MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820103015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
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 the bur broke at the shank during a craniotomy procedure.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.
Additional Manufacturer Narrative
The drill bit reported involved in this event was returned for evaluation.On receipt of the drill bit the reported malfunction of a broken drill bit was confirmed.The returned bur was evaluated by product engineering; the bur was observed to be broken.During the engineering evaluation, wear was noted on the drill neck.The location of the wear is external from the attachment.It is likely to have resulted from contact with hard material (most likely metallic) in the surgical site during use.This would have increased localized stress on the neck of the drill resulting in the break.This drill broke due to wear on the neck from metal contact during use.The associated handpieces for use with this drill bit instructions for use (ifu) contain the following indication for use; "when used with a variety of cutting accessories, the device is intended for surgical procedures involving the drilling of bone and hard tissue".
Event or Problem Description
It was reported that the bur broke at the shank during a craniotomy procedure.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.

• Brand Name: 1.5MM WIRE PASS DRILL BIT
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9694383
• Report Number: 0001811755-2020-00453
• Device Sequence Number: 11474209
• Product Code: HBE
• UDI-Device Identifier: 04546540362421
• UDI-Public: 04546540362421
• Combination Product (Y/N): N
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 5820103015
• Device Catalogue Number: 5820103015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1