MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L32MM; PLATE, FIXATION, BONE

Catalog Number	661432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/06/2019
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
It was reported: after fixation of the distal screw, the screw was broke.It seemed that the plate had some deflection when it was put in without tapping in a patient with good bone quality.It broke from the bottom of the screw head 5 mm, just over the contralateral cortex.Continued as is because there is no rescue equipment.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: note that only the broken screw head has been returned as the other part still remains implanted.Some close ups (done by the microscope) clearly show that the screw shaft got bent before breaking.This indicates that high mechanical force was applied and finally lead to this screw breakage.The broken surface shows the structures of a typical ductile overload breakage as well.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by to high mechanical force which was applied.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported: after fixation of the distal screw, the screw was broke.It seemed that the plate had some deflection when it was put in without tapping in a patient with good bone quality.It broke from the bottom of the screw head 5 mm, just over the contralateral cortex.Continued as is because there is no rescue equipment.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L32MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9397801
• Report Number: 0008031020-2019-02023
• Device Sequence Number: 1954040
• Product Code: HRS
• UDI-Device Identifier: 04546540686398
• UDI-Public: 04546540686398
• Combination Product (Y/N): N
• PMA/510(K) Number: K123964
• 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): 01/15/2020

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 661432
• Device Lot Number: Y30561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60