MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L28MM; PLATE, FIXATION, BONE

Catalog Number	661428S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Screw breakage occurred during axsos operation.According to 2.5 mm drill after pre-drill, then inserting the screw based on the procedure manual.However it got harder on the way and stopped moving.When further tightening by putting in force, it broke at the shaft of the screw.The broken screw end was remained in patient body.
Additional Manufacturer Narrative
The reported event that cortex screw axsos 3 ti ø3.5mm / l28mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by to much torsinal force (known very hard bone).The device inspection revealed the following: only the broken top part of the screw was returned, the broken screwshaft remained in the patient.Very strong deformation / damages of the inner torx are visible.This clearly indicates that far too much mechanical force beyond its calculated capability had been applied during screw insertion.A close up (done by the microscope) of the broken surface shows the structures of a typical ductile overload breakage.Note it was mentioned ¿ inserting got harder on the way and stopped moving.When further tightening by putting in force ,it broke at the shaft of the screw.¿ this gives us a clear indication that the predrilling may have not been deep enough, also in mind that the bone construction was very hard.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Screw breakage occurred during axsos operation.According to 2.5 mm drill after pre-drill, then inserting the screw based on the procedure manual.However it got harder on the way and stopped moving.When further tightening by putting in force ,it broke at the shaft of the screw.The broken screw end was remained in patient body.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L28MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8276290
• Report Number: 0008031020-2019-00048
• Device Sequence Number: 11105219
• Product Code: HRS
• UDI-Device Identifier: 04546540686367
• UDI-Public: 04546540686367
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• 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): 03/25/2019

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: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 661428S
• Device Lot Number: Y27035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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 Age: 24 YR