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Model Number 214124 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that the jaws of the expressew iii suture passer w/ hook were not opening.The complaint device was received and evaluated.Visual observations reveal the device is slightly worn, used but in expected condition.When the trigger was actuated to close and open the jaw, there was slight resistance.The upper jaw was loose when the jaws need to close; besides, it was not opening properly.It observed that jaws doesn't close normally contributing to the holding sample, therefore the functionality test with the needle was not performed.This complaint can be confirmed.This type of failure is typically observed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually break.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required at this point in time, based on the overall complaint rate for this failure mode, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
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Event Description
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It was reported by the sales rep via phone that the jaws of the expressew iii suture passer w/ hook are not opening.The rep does not have more information.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : according to the information provided, it was reported that the jaws of the expressew iii suture passer w/ hook were not opening.The complaint device was received and evaluated.Visual observations reveal the device is slightly worn, used but in expected condition.When the trigger was actuated to close and open the jaw, there was slight resistance.The upper jaw was loose when the jaws need to close; besides, it was not opening properly.It observed that jaws doesn't close normally contributing to the holding sample, therefore the functionality test with the needle was not performed.This complaint can be confirmed.This type of failure is typically observed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually break.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required at this point in time, based on the overall complaint rate for this failure mode, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Search Alerts/Recalls
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