MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM CARBIDE MATCH HEAD; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820107530C
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that the head of the bur broke during a posterior cervical fusion procedure.It was also reported that the fragment remains in the patient.It was further reported that there were no delays and no adverse consequences as a result of this event.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that the head of the bur broke during a posterior cervical fusion procedure.It was also reported that the fragment remains in the patient.It was further reported that there were no delays and no adverse consequences as a result of this event.It was also reported that the procedure was completed successfully.

• Brand Name: 3.0MM CARBIDE MATCH HEAD
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9139856
• Report Number: 0001811755-2019-03133
• Device Sequence Number: 3046780
• Product Code: HBE
• UDI-Device Identifier: 07613327294989
• UDI-Public: 07613327294989
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 5820107530C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1