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

Catalog Number	1608002035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, two burs broke in the attachment.No further information was provided.
Additional Manufacturer Narrative
The reported event, for bur breakage, was not confirmed as the bur was not returned for evaluation.Without the bur, the root cause cannot be determined.
Event or Problem Description
It was reported that during a surgical procedure, two burs broke in the attachment.No further information was provided.

• Brand Name: 4.0MM EGG 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: 8314890
• Report Number: 0001811755-2019-00497
• Device Sequence Number: 11009389
• Product Code: GFF
• UDI-Device Identifier: 04546540030580
• UDI-Public: 04546540030580
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 06/01/2023
• Device Catalogue Number: 1608002035
• Device Lot Number: 18180017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1