MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L40MM; PLATE, FIXATION, BONE

Model Number	661440
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981); Device Handling Problem (3265)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
Event or Problem Description
Primary left tibia procedure.It was reported that the 3.5 cortical screw was being inserted outside of the 20° cone of angulation in the shaft and was visibly bending during insertion.It is not known if the screw was aligned with the drill hole in the far cortex.The screw broke inside the patient.As the head was engaged with the plate and was not sitting proud, the surgeon made the decision to leave the entirety of the screw in the patient.Surgery was completed successfully with no delay.The rep may be able to obtain x-rays, and otherwise confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Primary left tibia procedure.It was reported that the 3.5 cortical screw was being inserted outside of the 20° cone of angulation in the shaft and was visibly bending during insertion.It is not known if the screw was aligned with the drill hole in the far cortex.The screw broke inside the patient.As the head was engaged with the plate and was not sitting proud, the surgeon made the decision to leave the entirety of the screw in the patient.Surgery was completed successfully with no delay.The rep may be able to obtain x-rays, and otherwise confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L40MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9394774
• Report Number: 0008031020-2019-01993
• Device Sequence Number: 1883368
• Product Code: HRS
• UDI-Device Identifier: 07613252580416
• UDI-Public: 07613252580416
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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 Model Number: 661440
• Device Catalogue Number: 661440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR