MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L36MM; PLATE, FIXATION, BONE

Model Number	661436S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
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
The customer reported that the head of the screw broke off during implantation, as it was being inserted by hand into an axsos plate the head did not fall into the patient.
Additional Manufacturer Narrative
The reported event could be confirmed (according to the photo provided), despite no further information.The device inspection (using the photo provided) revealed the following: the screw head is completely broken / torqued off at the upper level of the thread.The reported screw was not returned for investigation; however it is visible though that too much applied mechanical force during screw insertion has lead to the screw breakage.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 too much torque which was applied during screw insertion.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
Event or Problem Description
The customer reported that the head of the screw broke off during implantation, as it was being inserted by hand into an axsos plate the head did not fall into the patient.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L36MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9491410
• Report Number: 0008031020-2019-02289
• Device Sequence Number: 2080590
• Product Code: HRS
• UDI-Device Identifier: 04546540686404
• UDI-Public: 04546540686404
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 11/30/2023
• Device Model Number: 661436S
• Device Catalogue Number: 661436S
• Device Lot Number: Y41351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1