MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.6MM CROSS-CUT FISSURE; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820066016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a hyoid myotomy and suspension 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
The reported bur involved with this event was returned for evaluation and the reported failure of bur breakage was confirmed.The device was sent to the product engineering group who concluded that on inspection of the bur, damage consistent with metal contact was observed.Further witness marks were observed on the shaft of the bur indicating possible metal contact while in use.If the surgeon is drilling with the bur and applies pressure off axis this can cause fracture due to force applied.Contact with metal along with off axis cutting could have contributed to the bur breaking.The bur product label contains a symbol warning; "do not use excessive force." the instructions for use(ifu) of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the cutting accessory.".The associated devices ifu's state that the device and associated handpieces are "are intended to cut bone and bone cement in the following manner: drilling, reaming, decorating, shaping, and smoothing." the quality investigation is complete.
Event or Problem Description
It was reported that during a hyoid myotomy and suspension 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: 1.6MM CROSS-CUT FISSURE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8755190
• Report Number: 0001811755-2019-02190
• Device Sequence Number: 2280598
• Product Code: HBE
• UDI-Device Identifier: 04546540362353
• UDI-Public: 04546540362353
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 03/01/2024
• Device Catalogue Number: 5820066016
• Device Lot Number: 19080017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1