SMITH & NEPHEW, INC. UNKNOWN SUSPENSORY FIXATION DEVICE; 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 Problems
Hypoesthesia (2352); Hyperesthesia (4420)
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Event Date 09/01/2003 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Gobbi a, tuy b, mahajan s, panuncialman i.Quadrupled bone-semitendinosus anterior cruciate ligament reconstruction: a clinical investigation in a group of athletes.Arthroscopy.2003 sep;19(7):691-9.Doi: 10.1016/s0749-8063(03)00685-6.
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Event Description
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It was reported that on literature review ¿quadrupled bone-semitendinosus anterior cruciate ligament reconstruction: a clinical investigation in a group of athletes¿, after surgery with an endobutton, 8 patients experienced persistent hypoesthesia, at 12 months follow-up.No further information is available.
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Manufacturer Narrative
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H10: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.No further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H6: updated codes.
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Search Alerts/Recalls
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