MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM CARBIDE ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820110020C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
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 post-operatively, a fragment of a broken bur was observed in mri images.It was also reported the fragment remained in the patient.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.
Event or Problem Description
It was reported that post-operatively, a fragment of a broken bur was observed in mri images.It was also reported the fragment remained in the patient.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
The bur reported involved in this event was returned for evaluation where the bur returned was observed to be broke at the cutting end.The bur was evaluated by product engineering who concluded that this bur breakage is as a result of metal contact from the suction device during the procedure.The instruction for use(ifu) associated with attachments for use with this bur indicate the bur is for use as follows; "when used with these motors, the elite and heavy duty attachments and cutting accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting,extracting, removing, drilling, and reaming." the ifu also contains the following warning; "¿ do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the cutting accessory.".

• Brand Name: 2.0MM CARBIDE ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8905774
• Report Number: 0001811755-2019-02719
• Device Sequence Number: 2229919
• Product Code: HBE
• UDI-Device Identifier: 07613327294736
• UDI-Public: 07613327294736
• Combination Product (Y/N): N
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• 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 Expiration Date: 08/01/2020
• Device Catalogue Number: 5820110020C
• Device Lot Number: 18222017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/19/2019
• 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