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Catalog Number UNKN02100103 |
Device Problem
Failure to Align (2522)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 12/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources 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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Event Description
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It was reported that on literature review " distal locked screw misalignment in short head nail fixation for intertrochanteric fracture", one (1) was treated for a fracture classification a1 with an unkn trigen intertan intertroch antegr nail and patient experience a misalignment of distal interlocking screws.Patient had an special condition since the medullary cavity was narrow and the diameter of the nails was at least 10 mm, which could not be inserted in place however the distal dynamic hole was successfully inserted with a dynamic guide frame.No further information is available.
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Manufacturer Narrative
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Pdfs have been attached.
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Search Alerts/Recalls
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