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

Model Number 657318S

Device Problems Material Erosion (1214); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event 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 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.

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9345730
• MDR Text Key: 193324856
• Report Number: 0008031020-2019-01865
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086904
• UDI-Public: 07613327086904
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1