MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM; SCREW, FIXATION, BONE

Model Number 657314S

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "after opening the screw, white dust was sticky on the screw thread.".

Manufacturer Narrative

The reported event that locking screw variax2 t10, full thread, 3.5mm / l14mm was alleged of "dirt/residue" could be confirmed based on the picture provided.Due to the current covid-19 pandemic, it was not possible to receive the product for evaluation.The investigation will be reassessed as soon as the product is received.However, a picture was sent confirming the event.White particles are visible on the screw.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device return restricted due to pandemic.

Event Description

As reported: "after opening the screw, white dust was sticky on the screw thread.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10042304
• MDR Text Key: 193613919
• Report Number: 0008031020-2020-01444
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086850
• UDI-Public: 07613327086850
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657314S
• Device Catalogue Number: 657314S
• Device Lot Number: G15832
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 66