MAUDE Adverse Event Report: STRYKER TRAUMA GMBH FIXOS; SCREW, FIXATION, BONE

Model Number	705212
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Loaner screw set used for hardware removal.Surgeon attempted to remove old hardware with appropriate screwdriver for the previously implanted screw.The screwdriver broke in the attempt.The surgeon removed pieces and could see with room xray nothing was remaining.

• Brand Name: FIXOS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA GMBH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 18130396
• Report Number: 18130396
• Device Sequence Number: 12657826
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 07/18/2023
• Report Date (Section F): 07/18/2023

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: 705212
• Device Catalogue Number: 705212
• Device Lot Number: 13811G,
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 07/18/2023