MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5.0MM BARREL; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820017050
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke, the fragment was expelled in the operating room and the remainder of the bur stayed stuck in the associated handpiece drill.It was also reported that a replacement drill and a new bur was used to complete the surgery also broke during the procedure.No further information was provided.This report is for the second bur that broke.
Additional Manufacturer Narrative
Correction: d4 & h4: the manufacturing and expiry dates are unknown.As the lot number is unknown.Additional information: h3 & h6: the device was not returned for investigation.The quality investigation is complete.H3 other text : device discarded.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke, the fragment was expelled in the operating room and the remainder of the bur stayed stuck in the associated handpiece drill.It was also reported that a replacement drill and a new bur was used to complete the surgery also broke during the procedure.No further information was provided.This report is for the second bur that broke.

• Brand Name: 5.0MM BARREL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9284410
• Report Number: 0001811755-2019-03653
• Device Sequence Number: 2031200
• Product Code: HBE
• UDI-Device Identifier: 04546540374363
• UDI-Public: 04546540374363
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 05/01/2021
• Device Catalogue Number: 5820017050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1