STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; PLATE, FIXATION, BONE
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Model Number 657312S |
Device Problems
Positioning Failure (1158); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
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: "during the initial surgery on the clavicle (left), inserted the screw into the plate once and lock it.When the pulled out the screw to replace it with another one, a piece of metal was generated from the screw thread for locking the screw head".No further information is available.
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Manufacturer Narrative
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The reported event could be confirmed, since the device was returned and a thread could indeed be seen.The visual inspection showed the following: a metallic thread can be identified under microscope.The thread most probably resulted in an improper insertion of the screw, which lead to a shearing of some material from the threading of the device.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the insertion of the screw with an improper angle, which sheared off the thread, resulting in the debris.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 complaint report will be updated.
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Event Description
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As reported: "during the initial surgery on the clavicle (left), inserted the screw into the plate once and lock it.When the pulled out the screw to replace it with another one, a piece of metal was generated from the screw thread for locking the screw head".No further information is available.
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