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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that the patient developed a pin site infection forty four (44) days after the application of a jet-x system to treat a fracture of the tibia.Also, it was noticed that the pin was loose and sliding.The issue was resolved by an unplanned removal of the fixation system.The current state of health of the patient is unknown.This information was provided as part of a multi-device data collection activity associated to the jet-x pmcf study, therefore, no further details are available at this time.
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Manufacturer Narrative
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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this information provided was part of a multi-device data collection associated to the jet-x pmcf study.Per the complaint, no further information will be provided.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Event Description
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It was reported that the patient developed a pin site infection 44 days after the application of a jet-x system to treat a bimalleolar fracture and unstable pilon fracture on (b)(6) 2016.Also, it was noticed that the pin was loose and sliding through the calcaneus.The issue was resolved by removing the system on (b)(6) 2017.The current state of health of the patient is unknown.This information was provided as part of a multidevice data collection activity associated to the jet-x pmcf study, therefore, no further details are available at this time.
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Manufacturer Narrative
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Additional information: d6a, d6b.Corrected data: b3 (occurrence date), b5 (narrative), h6 (health effect - impact code).
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Search Alerts/Recalls
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