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Model Number 7210499 |
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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Internal complaint reference: (b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 was an isolated event.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 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 visual inspection revealed debris on the inner and outer blades.Some of the debris was reflective within the inner blade, implying metal shavings.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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The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 was an isolated event.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 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 visual inspection revealed debris on the inner and outer blades.Some of the debris was reflective within the inner blade, implying metal shavings.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.
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Manufacturer Narrative
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H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed debris and shedding on the inner blade with debris stuck between teeth and around outside of inner blade.Outer blade appears to have degradation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with unintended use of the device.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.H11: h2: corrected data on h6 (health effect - clinical code and health effect - impact code).
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Search Alerts/Recalls
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