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Model Number 72467305 |
Device Problems
Loose or Intermittent Connection (1371); Connection Problem (2900)
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Patient Problems
Arthritis (1723); Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
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Event Date 09/22/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis, patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.Revision surgery was performed to correct the problem.
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Manufacturer Narrative
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Results of investigation: it was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis.The patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.A revision surgery was performed to correct the problem.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A medical analysis noted that two undated, unlabeled x-rays confirmed the stated failure.However, without the requested relevant information, the root cause of the reported loosening cannot be determined.Technique error of the prep or selection for the screws cannot be ruled out as well the quality of the bone as it could play a factor in this failure.Based on the limited information provided, the impact to the patient beyond the revision cannot be determined.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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Manufacturer Narrative
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It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis.The patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.A revision surgery was performed to correct the problem.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows some plate holes are deformed/damaged.A dimensional analysis was conducted and noted that all measurable device features are within specifications.Features that cannot be accurately measured, due to damage incurred during previous use.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A medical analysis noted that two undated, unlabeled x-rays confirmed the stated failure.However, without the requested relevant information, the root cause of the reported loosening cannot be determined.Technique error of the prep or selection for the screws cannot be ruled out as well the quality of the bone as it could play a factor in this failure.Based on the limited information provided, the impact to the patient beyond the revision cannot be determined.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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Search Alerts/Recalls
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