MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM COARSE DIAMOND ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820013020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure on the spine, the tip of the bur broke.It was also reported that the tip was completely removed.It was further reported that there were no delay and no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The bur broke due to sustained contact with separate surgical tool (most likely metallic) in the surgical site causing wear to develop on the head of the drill resulting in the breakage.
Event or Problem Description
It was reported that during a procedure on the spine, the tip of the bur broke.It was also reported that the tip was completely removed.It was further reported that there were no delay and no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: 2.0MM COARSE DIAMOND ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8246083
• Report Number: 0001811755-2019-00139
• Device Sequence Number: 11249386
• Product Code: HBE
• UDI-Device Identifier: 04546540374271
• UDI-Public: 04546540374271
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 5820013020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1