MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number	657316S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2020
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: "during screw operation of variax fibra, locking failure of the screw occurred.I tried to use the same screw in another screw hole, but it did not lock as well.When the new screw was opened and used, it locked normally.The doctor said the thread on the screw might have been scraped when the screw was inserted".
Additional Manufacturer Narrative
The reported event could be confirmed.The returned device was inspected under a microscope.The threads of the locking mechanism below the screw heads saw a plastic deformation (to various extend) which could explain the loss of the angular and straight locking ability.The device is no longer functional.The threads of the main part of the screw also show some deformation.This could have been due to the insertion of the screw with a too big of an angle, which could have deformed the main part of the screw too.Based on investigation, the root cause was most probably user related.The failure was caused by inadequate use of the screw during insertion.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 additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during screw operation of variax fibra, locking failure of the screw occurred.I tried to use the same screw in another screw hole, but it did not lock as well.When the new screw was opened and used, it locked normally.The doctor said the thread on the screw might have been scraped when the screw was inserted".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10182035
• Report Number: 0008031020-2020-01722
• Device Sequence Number: 11662641
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (Y/N): N
• PMA/510(K) Number: K132502
• 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): 09/24/2020

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: 10/31/2024
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: D54952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1