MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM ROUND BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	1608002055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
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 on the hand, the bur broke at the notch end.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The bur reported involved in this event was returned for evaluation.On receipt of the bur the reported issue of bur breakage was confirmed.The returned bur was evaluated by product engineering who concluded that markings observed on the bur flutes are consistent with metal contact while cutting.It is possible that the contact with metal while cutting with the bur caused the bur to break.The instructions for use(ifu) associated with drills for use with this bur contain the following indications for use statement; "when used with a variety of cutting accessories, the remb electric micro drill is intended for surgical procedures involving the drilling of bone and hard tissue, including the spine.".
Event or Problem Description
It was reported that during a surgical procedure on the hand, the bur broke at the notch end.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 4.0MM ROUND 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: 8522911
• Report Number: 0001811755-2019-01214
• Device Sequence Number: 13924140
• Product Code: GFF
• UDI-Device Identifier: 04546540030658
• UDI-Public: 04546540030658
• 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): 06/13/2019

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: 1608002055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1