STRYKER GMBH DISTAL TARGETING ARM FEMUR ANTEGRADE IMN INSTRUMENTS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 23533106 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device retained by the hospital.
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Event Description
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As reported: "during surgery of t2alpha-gt right, the sleeve did not reach the bone when using the distal device.Cause unknown.Maybe due to patient's anatomy.".
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.Lot# kme915035 was manufactured in three different batches.Since the serial # of the affected device was not communicated, it is not possible to know to which batch it corresponds.Therefore, the exact manufacturing date could not be determined.Nonetheless, the production documents of all three batches were reviewed.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: "during surgery of t2alpha-gt right, the sleeve did not reach the bone when using the distal device.Cause unknown.Maybe due to patient's anatomy.".
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Search Alerts/Recalls
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