SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 66MM FOR IM NAILS; SCREW, FIXATION, BONE
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Model Number 04.005.556 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/25/2022 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2022, there was a concern over the stability of fx: removal of nail and screws.An im reaming of femoral canal was completed.The surgeon put in larger nail / supplement with a proximal femur hook plate.This report is for one (1) 5.0 ti lckng scr t25 sd 66 for im nails.This is report 5 of 5 for complaint (b)(4).
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Manufacturer Narrative
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Product complaint #(b)(4).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.Patient identifier mrn: (b)(6).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.Health effect- clinician code 2402 used to capture injury.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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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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