MAUDE Adverse Event Report: STRYKER TRAUMA SA AXSOS; SCREW, FIXATION, BONE

Model Number	703586
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While performing a tibial plateau fracture open reduction internal fixation, two drill bits broke inside the patient's tibia.Broken drill bits left inside the patient's bone as it would require significant effort and likely cause more harm to remove then.

• Brand Name: AXSOS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA SA; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9595683
• Report Number: 9595683
• Device Sequence Number: 16818568
• Product Code: HWC
• UDI-Device Identifier: 04546540694089
• UDI-Public: (01)04546540694089
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/03/2020
• Report Date (Section F): 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 703586
• Device Catalogue Number: 703586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 113
• Date Report Sent to FDA: 01/03/2020