SMITH & NEPHEW, INC. UNKN PEEK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202901 |
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 04/01/2021 |
Event Type
Injury
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Event Description
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It was reported that on literature review "repair integrity and functional outcomes between knot-tying and knotless suture-bridge arthroscopic rotator cuff repair: a prospective randomized clinical trial", one patient had a post-operative superficial active infection after a knot-tying rotator cuff repair procedure using a footprint anchor.This event was treated by administration of oral antibiotics.The patient was full recovered.No further information is available.
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).Article cite: sahin, k., sentürk, f., ersin, m., arzu, u., chodza, m., & ersen, a.(2021).Repair integrity and functional outcomes between knot-tying and knotless suture-bridge arthroscopic rotator cuff repair: a prospective randomized clinical trial.Orthopaedic journal of sports medicine, 9(4), 23259671211002482.Https://doi.Org/10.1177/23259671211002482.
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Manufacturer Narrative
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The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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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