MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X16MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48844016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that fixation pin for the plate broke at the distal end during screwing in.The distal end stayed into the patient.The round head part of the screw broke apart.New screw was implanted.Surgical delay of 30min is reported.No adverse consequences is reported.
Additional Manufacturer Narrative
The screw was reported to have a fractured tab during implantation.Manufacturing history was reviewed and no anomalies were found.Material analysis was performed and found that the screw fractured in ductile overload.The elemental constitution was as specified on the drawing.No material or manufacturing defects were found.The sales representative reported that the patient had hard bone quality which is the likely cause of the tab fracture.
Event or Problem Description
It is reported that fixation pin for the plate broke at the distal end during screwing in.The distal end stayed into the patient.The round head part of the screw broke apart.New screw was implanted.Surgical delay of 30min is reported.No adverse consequences is reported.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X16MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7483033
• Report Number: 0009617544-2018-00103
• Device Sequence Number: 1125104
• Product Code: KWQ
• UDI-Device Identifier: 07613252254713
• UDI-Public: (01)07613252254713
• Combination Product (Y/N): N
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: No Information
• Device Model Number: 48844016
• Device Catalogue Number: 48844016
• Device Lot Number: WWS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1