MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0 ELITE DIAMOND COARSE; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820013030
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
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 nurse noticed the package of the bur was open.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully using a back-up bur.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the nurse noticed the package of the bur was open.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully using a back-up bur.

• Brand Name: 3.0 ELITE DIAMOND COARSE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11039424
• Report Number: 0001811755-2020-03521
• Device Sequence Number: 16459982
• Product Code: HBE
• UDI-Device Identifier: 04546540346575
• UDI-Public: 04546540346575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 07/01/2025
• Device Model Number: 5820013030
• Device Catalogue Number: 5820013030
• Device Lot Number: 20211017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1