SMITH & NEPHEW, INC. UNKNOWN METAL SUTURE ANCHOR; 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 Problem
Joint Dislocation (2374)
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Event Date 01/01/2021 |
Event Type
Injury
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Event Description
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It was reported that on literature review do techniques for hill-sachs remplissage matter in terms of functional and radiological outcomes, 2 patients had postoperative shoulder instability after an arthroscopic bankart repair procedure using two twinfix anchors and a sharp tissue penetrator device.Both patients underwent revision surgery using the arthroscopic latarjet procedure.They remained symptom free at the final follow-up (36 and 48 months).No further information is available.
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Manufacturer Narrative
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Internal complaint reference: case(b)(4).Doi: 10.1177/23259671211008152.Pulatkan, a., kapicioglu, m., ucan, v., masai, m.N., ozdemir, b., akpinar, s., & bilsel, k.(2021).Do techniques for hill-sachs remplissage matter in terms of functional and radiological outcomes?.Orthopaedic journal of sports medicine, 9(6), 23259671211008152.
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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 relationship found between the device and 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.A clinical review states 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.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and an instructions for use/device labeling review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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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