STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L55MM; SCREW, FIXATION, BONE
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Model Number 657355S |
Device Problems
Positioning Failure (1158); Material Fragmentation (1261)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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As reported: metal fragments were observed when a non-locking screw was inserted in the oval hole and a locking screw in the round hole, respectively.Only the metal fragments were retrieved.The locking screw did not lock upon insertion and was spinning all the time.
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Manufacturer Narrative
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The reported event could not be confirmed.Only the material fragmentation could be confirmed, based on the fragments returned.However, since the screws were not returned, it was not possible to perform a proper inspection and to determine the root cause of the material fragmentation.It was also impossible the determine to which screw each fragment belonged.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.
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Event Description
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As reported: "event1: metal fragments were observed when a non-locking screw was inserted in the oval hole and a locking screw in the round hole, respectively.Only the metal fragments were retrieved.Event2: the locking screw did not lock upon insertion and was spinning all the time.".
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