STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L48MM; SCREW, FIXATION, BONE
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Model Number 657322 |
Device Problems
Positioning Failure (1158); Material Fragmentation (1261)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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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.".
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Manufacturer Narrative
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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 substantial 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.
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Event Description
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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.".
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