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Catalog Number UNKN02200702 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Non-union Bone Fracture (2369)
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Event Type
Injury
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Event Description
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It was reported that, following an talus (subtalar) arthrodesis surgery performed on an unspecified date with large cannulated screw, the patient sustained non-union and notable pain as clinical outcomes.Although the patient was followed up for nineteen (19) months, an onset date for the reported symptoms could not be identified.Patient required revision surgery for removal of metalwork and insertion of a hindfoot nail with bone grafting at nineteen (19) months.Bone united successfully.No further information is available.
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Manufacturer Narrative
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Internal reference number: (b)(4).H10: this complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.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.
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Search Alerts/Recalls
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