MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW AXSOS 3 TI 4.0MM / L30MM / FULL THREAD; PLATE, FIXATION, BONE

Model Number	607330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the heads broke off when the screws were screwed in.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received cancellous screw was found to be broken.The study of microscopic image of fracture surface and its appearance confirms that this is a brittle overload fracture (torsional).Brittle fracture results from the application of excessive force to a part that does not have the ability to deform plastically before breaking.Brittle fractures frequently have chevron marks pointing to the origin of the fracture, which were shown in the image.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿avoid surface damage of implants.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused due to application of high torsional forces while screwing in the cancellous screw which could be confirmed during the visual inspection as origin of fracture and chevron marks are clearly visible confirming it to be a brittle overload fracture.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the heads broke off when the screws were screwed in.".

• Brand Name: CANCELLOUS SCREW AXSOS 3 TI 4.0MM / L30MM / FULL THREAD
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10451920
• Report Number: 0008031020-2020-02190
• Device Sequence Number: 19634026
• Product Code: HRS
• UDI-Device Identifier: 07613252578536
• UDI-Public: 07613252578536
• Combination Product (Y/N): N
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 607330
• Device Catalogue Number: 607330
• Device Lot Number: V08685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1