SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 04.038.390S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 10/05/2022 |
Event Type
Injury
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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.Additional device product codes: hsb.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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.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 japan as follows: it was reported that on (b)(6) 2022, the patient underwent open reduction/internal fixation for a femoral intertrochanteric fracture with the products in question.The surgeon used a 90mm blade, but the anterior posterior image showed it just on the articular surface, and the other image showed the blade tip perforating the head of the bone slightly.He set the blade back about 3 mm, also set the memory of the cannula to 85 mm and under, and carefully injected 5 to 6 mm of cement.No cement leaked onto the joint surfaces.The surgery was completed successfully within 30 minutes surgical delay.The patient status is reported as stable.No further information is available.This report involves one tfna fenestrated helical blade 90mm - sterile.This is report 1 of 1 for (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.H3, h4, h6: device history lot a dhr review could not be performed for this pi.Lot and part combination is not available.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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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