MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CROSS CUT FISSURE 1.6MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0277010216
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
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 the bur broke during a teeth extraction surgery.It was further reported that a spare bur was used to complete the surgery.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.
Event or Problem Description
It was reported that the bur broke during a teeth extraction surgery.It was further reported that a spare bur was used to complete the surgery.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.
Additional Manufacturer Narrative
Updated initial reporter and occupation.Device evaluation: investigation results indicate that contact with material other than tooth/bone along with off axis cutting could have contributed to the breakage.The quality investigation is complete.

• 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: 9220410
• Report Number: 0001811755-2019-03280
• Device Sequence Number: 19546189
• 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): 12/10/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1