MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM; SCREW, FIXATION, BONE

Model Number	657318S
Medical Device Problem Codes	Material Erosion (1214); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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
Variax clavicle operation.When the locking screw was inserted, a thread-like metal piece came out from between the plate and the screw.Replaced with a new locking screw of the same size.The operation ended successfully.
Event or Problem Description
Variax clavicle operation.When the locking screw was inserted, a thread-like metal piece came out from between the plate and the screw.Replaced with a new locking screw of the same size.The operation ended successfully.
Additional Manufacturer Narrative
The reported event could be confirmed.The inspection revealed that the foreign material is a metallic wire.The microscope investigation showed that the threaded part of the screw is missing some material.Moreover, the metallic wire has the same color as the screw.Therefore, most probably, while tightening the screw, the metallic wire came out.The wire came out most likely because the screw was inserted with too big of an angle (the smart lock technology allows the surgeon to aim and lock the screw within a 30° cone), which could have caused the friction between the screw and a sharp part of the plate (the titanium lip for instance), leading to the removal of a part of the material.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.If any further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9345730
• Report Number: 0008031020-2019-01865
• Device Sequence Number: 2801723
• Product Code: HWC
• UDI-Device Identifier: 07613327086904
• UDI-Public: 07613327086904
• 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): 02/05/2020

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: 07/31/2023
• Device Model Number: 657318S
• Device Catalogue Number: 657318S
• Device Lot Number: Y19610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1