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Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that following a second surgical intervention on (b)(6) 2019 (osteosynthesis was performed with an anatomical clavicle plate) an infection at the site of the osteosynthesis material appeared and made the material loose again.Dr.(b)(6) decided to remove the material, wash, debride and close.In the institution they send the material to an internal process called sonication, it is not returned or sent to quality.] this complaint involves fourteen (14) devices.This is 3 of 9 for report (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: updated event description.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The patient underwent an osteosynthesis of a sterno-clavicular dislocation with a blocked sternum system, on (b)(6) 2019, surgeon place the emergency rod upside down, because it was uncomfortable, it is explained that the system is indicated for sternum closure and that rod blocks and secures the plate, the system fails and the patient must be re-operated at 8 days (b)(6) 2019) on that occasion an anatomical clavicle plate with lateral extension was used at each side, from the sternum to the clavicle.It was found that to turn the emergency rod up was the reason of system failure.The patient had a second intervention on (b)(6), during which osteosynthesis was performed with an anatomical clavicle plate; but the osteosynthesis material became infected and loosened again, surgeon removes the material, wash, debris and close.The institution sent materials for sonication-an internal process.
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Event Description
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It was reported that on (b)(6) 2019, the patient diagnosed with a bilateral sternoclavicular dislocation underwent an osteosynthesis with a sternum plate, the surgeon decided on that occasion to place the plate safety hook upside down, which caused the system to loosen.On (b)(6) 2019, this osteosynthesis material was removed at the institution, and the sternoclavicular dislocation fixation was performed again bilateral with anatomical bilateral clavicle plate.This material failed again, became infected and loosened.The surgeon decided to remove the material, wash, debride and close.Finally, on (b)(6) 2020, the patient is reoperated again to do anatomical reduction with an x-shaped polyester suture.This report captures the second event of material loosening and infection while related (b)(4) captures the first event of sternal plate loosening.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: additional information and updated event description device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D6a d6b: explantation date is unknown.
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Event Description
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Additional event information this report was clarified that this report was reported since 2019 and this is the fourth reintervention of the patient since that date, the first report has already been had closed.On , the patient diagnosed with a bilateral sternoclavicular dislocation underwent an osteosynthesis with a sternum plate, the surgeon decided on that occasion to place the plate safety hook upside down, which caused the system to loosen.On (b)(6) 2019, this osteosynthesis material was removed at the institution, the sternoclavicular dislocation fixation was performed again bilateral with bilateral clavicle anatomical plate, this material again failed, became infected and loosened, the surgeon decided to remove the material, wash, debride and close.Finally, on (b)(6) 2020, the patient is reoperated again.The surgeon decides to do anatomical reduction with an x-shaped polyester suture, the procedure was performed in the company of the institution's thorax surgeon.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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