|
Model Number 71640640 |
Device Problem
Fracture (1260)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 01/01/1901 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post market clinical follow up activity sponsored by smith and nephew.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
|
|
Event Description
|
It was reported that the patient suffered from the breakage of screws in the nail after having a fracture fixation surgery of the right femur using the trigen meta-tan system.No hardware revision surgery was scheduled.Overall, alignment was maintained, without complication.Patient has healed well and has no pain.The patient achieved union at 53.7 weeks after the primary surgery.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
|
|
Manufacturer Narrative
|
H10: additional information in d10.H11:corrected information in d1, d2, and d4.
|
|
Search Alerts/Recalls
|
|
|