MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L32MM; SCREW, FIXATION, BONE

Model Number 657322

Device Problems Positioning Failure (1158); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "the surgeon tried to fix the calcaneus mesh plate with 3.5 mm variax2 locking screws during surgery.7 screws from the mesh were not tightened, went loose and a small chip came off the thread of some of them.Replacements were available to complete the medical procedure successfully.".

Manufacturer Narrative

Correction: section d4 (catalog #, gtin).The reported event could be confirmed.The device inspection revealed the following: the 7 screws were returned but without the plate.The devices were inspected under a microscope.The threads of the locking mechanism below the screw heads show a plastic deformation (to various extents) for all 7 screws which could explain the loss of the angular locking ability.A straight locking of the screws on the plate could however be performed for 6 out of the 7 screws.One of the screws with lot number d13348 has a thread damage too substential to be able to lock.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 further information is provided, the investigation report will be updated.

Event Description

As reported: "the surgeon tried to fix the calcaneus mesh plate with 3.5 mm variax2 locking screws during surgery.7 screws from the mesh were not tightened, went loose and a small chip came off the thread of some of them.Replacements were available to complete the medical procedure successfully.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L32MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10379523
• MDR Text Key: 202070482
• Report Number: 0008031020-2020-02089
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086959
• UDI-Public: 07613327086959
• Combination Product (y/n): N
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657322
• Device Catalogue Number: 657332
• Device Lot Number: D13359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1