SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.037.115S |
Device Problem
Break (1069)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Event Description
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Device report from australia reports an event as follows: it was reported that patient was treated on (b)(6) 2020, for nof fracture with a trochanteric fixation nail advanced (tfna) 235mm nail, blade, and was augmented with traumacem.On (b)(6) 2021, the patient presented to clinic with progressive lateral thigh pain which had increased over the last twelve months.Upon imaging, the initial nof fracture appears to be healed but the tfna nail had fractured at the proximal aperture and the blade had migrated laterally.As of (b)(6) 2022, the patient still had lateral thigh pain but did not want further operations to remove the implants.This report is for a 11mm/125 deg ti cann tfna 235mm/left - sterile.This is report 1 of 2 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.(b)(6).Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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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Search Alerts/Recalls
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