SMITH & NEPHEW, INC. MENISCAL STITCHER STR REPL (PKG 1); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 72202868 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 08/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Hrishikesh pande, prashant pratim padhi, m.Bhattacharya, functional outcome of arthroscopic repair of bucket handle and longitudinal medial meniscal tears in a military population by inside out and outside in technique: a prospective observational study., journal of arthroscopy and joint surgery, volume 7, issue 3, 2020,pages 137-144,issn 2214-9635, doi:10.1016/j.Jajs.2020.07.003.
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Event Description
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It was reported that on literature review "functional outcome of arthroscopic repair of bucket handle and longitudinal medial meniscal tears in a military population by inside out and outside in technique: a prospective observational study", after using a meniscal stitcher set smith&nephew device, 4 patients experienced superficial surgical site infection, it was treated with antibiotics.No further information is available.
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Manufacturer Narrative
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H3, h6: 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 an isolated event.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.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.
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