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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Adhesion(s) (1695)
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Event Date 05/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Article: factor, s., khoury, a., atzmon, r., vidra, m., amar, e., & rath, e.(2020).Combined endoscopic and mini-open repair of chronic complete proximal hamstring tendon avulsion: a novel approach and short-term outcomes.Journal of hip preservation surgery, 7(4), 721-727.
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Event Description
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It was reported that on literature review ¿combined endoscopic and mini-open repair of chronic complete proximal hamstring tendon avulsion: a novel approach and short-term outcomes ¿, after surgery with a 3.5 full radius shaver one patient had subcutaneous scarring requiring revision surgery to lysis of adhesions.No further information is available.
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Manufacturer Narrative
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Internal complaint reference (b)(4).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, complaint history review, instructions for use/device labeling review and risk management review could not be conducted.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all of the attached images.Therefore, no further interpretation of the attached images are required.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.
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Search Alerts/Recalls
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