SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ACROMIOBLASTER BURR; SAW, POWERED, AND ACCESSORIES
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Model Number 72200731 |
Device Problem
Flaked (1246)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2020 |
Event Type
Injury
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Event Description
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It was reported that during arthroscopic shoulder surgery, the surgeon was complaining of shedding on the shaver blade.The procedure was completed with the same device and no other complications were reported.Minor delay to clear metal shavings from joint.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that there was significant debris in the inner and outer blades.Some of the debris was reflective on the inner blade, implying metal shavings.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this is a repeated event.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.A review of the instructions for use revealed the following warnings and precautions related to the reported failure: read these instructions completely prior to use.Dyonics disposable arthroscopic blades contain magnets that may be attracted to other instrumentation when placed in direct contact.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include excessive side-loading and minimal irrigation.No containment or corrective actions are recommended at this time.
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Manufacturer Narrative
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Device is available for evaluation, device was returned to manufacturer on (b)(6) 2020.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).H10 h3,h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed a significant amount of dried saline on the inner and outer blade.There was a small metal shaving on the burr of the inner blade.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this is a repeat event.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.A review of the instructions for use revealed the following warnings and precautions related to the reported failure: read these instructions completely prior to use.Dyonics disposable arthroscopic blades contain magnets that may be attracted to other instrumentation when placed in direct contact.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include side-loading.No containment or corrective actions are recommended at this time.
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