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Model Number 04.038.000S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint number: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Part: 04.038.000s, lot: 272p826, manufacturing site: (b)(4).Release to warehouse date: 26 july 2021.Expiry date: 01 july 2031, a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 on (b)(6) 2021, the patient underwent an open reduction internal fixation with the trochanteric fixation nail- advanced for the fracture of the diaphyseal femur.The surgery was completed successfully without any surgical delay.After the surgery, secondary fracture had occurred.A tfna fenestrated helical blade 90mm ¿ sterile, tfna femoral nail ø11 125° l200 timo15, lockscrew ø5 l34 f/nails tan- light green, and a tfna end cap extension 0 tan were used during the procedure.On (b)(6) 2022, the revision surgery was performed to remove the trochanteric fixation nail- advanced and fix the fracture with a long gamma nail and screws.According to the surgeon, this event was caused by a technical error due to poor implant insertion point, not product malfunction.The surgeon thought that the patient had not fallen.The surgeon guessed that the secondary fracture may be a stress fracture because the insertion point was posterior, and the tip of nail was hitting the anterior cortical bone.No further information is available.The procedure was successfully completed.The patient outcome is reported as stable.This report is for one (1) tfna end cap extension 0 tan.This is report 1 of 4 for complaint (b)(4).
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Search Alerts/Recalls
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