MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CROSS CUT FISSURE 1.6MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0277010216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
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 two burs broke at the cutting end during a tooth extraction.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.This report is for the second bur that broke.
Event or Problem Description
It was reported that two burs broke at the cutting end during a tooth extraction.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.This report is for the second bur that broke.
Additional Manufacturer Narrative
H6; the bur reported involved in this event was not returned for evaluation.Without the bur the reported malfunction of breakage was not confirmed.Device discarded by customer.

• Brand Name: CROSS CUT FISSURE 1.6MM
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8912767
• Report Number: 0001811755-2019-02744
• Device Sequence Number: 16214790
• Product Code: GFF
• UDI-Device Identifier: 04546540050502
• UDI-Public: 04546540050502
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 10/29/2019

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: 0277010216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1