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

Model Number	5820107530C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.It was also reported that a delay of 2 minutes was caused by the event.It was further reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; 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.H3 other text : device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke.It was also reported that a delay of 2 minutes was caused by the event.It was further reported there were no adverse consequences as a result of this event.It was further 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: 9475365
• Report Number: 0001811755-2019-04072
• Device Sequence Number: 2763801
• Product Code: HBE
• UDI-Device Identifier: 07613327294989
• UDI-Public: 07613327294989
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/30/2020

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 Model Number: 5820107530C
• Device Catalogue Number: 5820107530C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1