MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; SCREW, FIXATION, BONE

Model Number	657312
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
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
Primary procedure, left fibula.It was reported that the variax 2 3.5 x 12mm locking screw popped when seated into the plate, and then spun freely instead of locking.A variax 1 screw was used to complete the procedure successfully with a delay of less than a minute.
Event or Problem Description
Primary procedure, left fibula.It was reported that the variax 2 3.5 x 12mm locking screw popped when seated into the plate, and then spun freely instead of locking.A variax 1 screw was used to complete the procedure successfully with a delay of less than a minute.
Additional Manufacturer Narrative
The reported event could not be confirmed.The returned screw doesn't show any significant signs of damage except some discoloration under the screw head that was noticed.Based on investigation, the root cause could not be established.Based on available information, no further action is required at this time.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 further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10299927
• Report Number: 0008031020-2020-01933
• Device Sequence Number: 2853808
• Product Code: HWC
• UDI-Device Identifier: 07613327086812
• UDI-Public: 07613327086812
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• 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): 11/17/2020

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: 657312
• Device Catalogue Number: 657312
• Device Lot Number: D43415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR