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
Awaiting device evaluation.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 first 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 first bur that broke.
Additional Manufacturer Narrative
The bur reported involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to product engineering for evaluation who concluded that based on the analysis carried out, it is reasonable to suggest that at some point during operation the bur was subjected to an excessive bending moment, or experienced shock loading due to contact with metal, which overloaded the bur and caused it to fracture.The ifu of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure.Monitor heavy sideloads and/or long operating periods to prevent overheating of the distal tip and body of the handpiece and/or attachment.Excessive pressure may bend or fracture the cutting accessory" the associated devices ifu's state that the device and associated handpieces are "intended for surgical procedures involving the drilling of bone and hard tissue, including the spine.".

• 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: 8912766
• Report Number: 0001811755-2019-02743
• Device Sequence Number: 13854671
• 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): 10/22/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1