Catalog Number 319.01 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
Sedation (2368)
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Event Date 07/21/2015 |
Event Type
Injury
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Event Description
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It was reported that during a wrist fusion surgery, it was noted that a depth gauge was not assembled correctly.Another depth gauge was inserted into the first depth gauge which threw off all measurements for screw length.There were six (6) screws that were implanted and had to be removed due to being too long, secondary to these measurements.There was no malfunction with the screws.There was a thirty (30) minute surgical delay.No further patient harm was reported and surgery was completed successfully.The procedure was a revision procedure involving a non-synthes implant that had been implanted thirty (30) years ago.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Patient id: (b)(6).Patient weight is unknown.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the service history records has been requested.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.
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Manufacturer Narrative
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Additional narrative: a service history review was performed ¿ no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 14-dec-2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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.
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Manufacturer Narrative
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Additional narrative: subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device 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.
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Manufacturer Narrative
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Additional narrative: the device was returned to the customer prior to the completion of an evaluation.Therefore, no investigation information/results are available for reporting.Device 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.Returned to customer prior to evaluation.
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Search Alerts/Recalls
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