MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM DMND MTCH HD, 16CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8470107030D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that when performing spinal surgery, the bur broke into two pieces.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
Investigation results indicate that the bur experienced a high axial force which increased the stress at the mid bearing causing the bur to fracture at the location where heat and wear developed.The ifu for attachments associated with these cutting accessories warns the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the cutting accessory." the quality investigation is complete.
Event or Problem Description
It was reported that when performing spinal surgery, the bur broke into two pieces.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: 3.0MM DMND MTCH HD, 16CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7406471
• Report Number: 0001811755-2018-00574
• Device Sequence Number: 173448
• Product Code: HBE
• UDI-Device Identifier: 07613327097214
• UDI-Public: (01)07613327097214
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 05/21/2018

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: 01/01/2021
• Device Model Number: 8470107030D
• Device Catalogue Number: 8470107030D
• Device Lot Number: 16019017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1