MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	0277010421
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
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 during a surgical procedure, the bur broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Originally, the complaint detailed that the affected product was a 2.1mm cross-cut fissure carbide bur, with a part number (p/n) of 0277-010-421 from lot number 1714607.This description matches the label on the opened packaging returned with the complaint part.However, on inspection it was determined that the complaint part is a 1.2mm cross-cut fissure carbide bur with a p/n of 0277-010-212 from an unknown lot number.The reported product involved with this event was returned for evaluation and the reported failure of bur break was confirmed.The device was sent to product engineering who concluded that based on the analysis carried out, it is reasonable to suggest that at some point during operation the bur experienced shock loading due to contact with metal, which overloaded the bur and caused it to fracture.The instruction for use(ifu) associated with attachment/handpieces for use with this bur contain the following warning; "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.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 1.2MM CROSS-CUT FISSURE CARBIDE BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9469013
• Report Number: 0001811755-2019-04047
• Device Sequence Number: 3103599
• Product Code: GFF
• UDI-Device Identifier: 04546540050625
• UDI-Public: 04546540050625
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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 Expiration Date: 05/01/2022
• Device Model Number: 0277010421
• Device Catalogue Number: 0277010212
• Device Lot Number: 17146017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1