MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.2MM CROSS CUT FISSURE; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5120066012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
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.
Event or Problem Description
It was reported during a maxillo facial surgery of dental extraction with supernumerary mandibular tooth that the bur broke during a surgical procedure.It was also reported that the broken piece was retrieved from the patient.It was further reported that a second bur was opened and used to complete the case, there was a minor delay to retrieve the fragment.It was also reported that the bur which broke was reprocessed/reused.It was also reported that there were 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.Based on the analysis results, it is reasonable to suggest that at some point during operation the bur was subjected to an excessive bending moment which overloaded the bur and caused it to fracture.
Event or Problem Description
It was reported during a maxillo facial surgery of dental extraction with supernumerary mandibular tooth that the bur broke during a surgical procedure.It was also reported that the broken piece was retrieved from the patient.It was further reported that a second bur was opened and used to complete the case, there was a minor delay to retrieve the fragment.It was also reported that the bur which broke was reprocessed/reused.It was also reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: 1.2MM CROSS CUT FISSURE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8001594
• Report Number: 0001811755-2018-01772
• Device Sequence Number: 13780936
• Product Code: HBE
• UDI-Device Identifier: 04546540078612
• UDI-Public: 04546540078612
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/12/2019

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: No Information
• Device Catalogue Number: 5120066012
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1