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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Contracture (4528)
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Event Date 08/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Article: çaglar, c., yagar, h., emre, f., & ugurlu, m.(2021).Mid-term outcomes of arthroscopic suture fixation technique in tibial spine fractures in the pediatric population.Turkish journal of trauma and emergency surgery, 27(5), 571-576.
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Event Description
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It was reported that on literature review "mid-term outcomes of arthroscopic suture fixation technique in tibial spine fractures in the pediatric population", 1 patient experienced a 30° flexion contracture due to arthrofibrosis development after an arthroscopic suture fixation procedure.This event required a revision surgery for synovium debridement and release protocol performing.Patient outcome is unknown.No further information is available.
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Manufacturer Narrative
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H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.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 there was insufficient information to tie the reported complaint to specific line items within the risk file.Our clinical investigation concluded: 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.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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