ARTHROCARE CORPORATION UNKNOWN ULTRABUTTON DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of the specific registry from specific country 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 registry review pms-247 new zealand acl registry ad hoc report feb 2022 , one (1) patient presented a chondral pathology after an acl procedure using two (2) ultrabutton.The patient required an additional surgery for chondroplasty.Patient current status is unknown.No further information is available.
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Manufacturer Narrative
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Corrected data: this complaint was opened by smith+nephew to document a patient complication identified through a review of the 2022 new zealand acl registry ad hoc report from new zealand 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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