MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM X-COARSE DIAMOND ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820013140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke at the cutting end.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 using a spare bur.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke at the cutting end.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 using a spare bur.

• Brand Name: 4.0MM X-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: 8811408
• Report Number: 0001811755-2019-02318
• Device Sequence Number: 10827889
• Product Code: HBE
• UDI-Device Identifier: 04546540374295
• UDI-Public: 04546540374295
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 5820013140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1