Model Number N/A |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported the knob at the bottom of the driver when turned did not engage the blade and would not turn.Normally there are two drivers in each set so a back-up driver would be available; however it was reported the set at this facility had one driver.The surgeon completed the procedure by accessing the scapula to fixate the last rib; no additional incisions were made.There was no patient injury and a surgical delay of fifteen minutes.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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The product identity was confirmed in the evaluation.The device history records were reviewed for the lot and no non-conformances were found.The driver was visually evaluated and it shows signs of normal use.The complaint was confirmed as when the handle (knob) was rotated, an inserted blade did not rotate.It was noticed that the head of the driver was a little loose and able to be screwed back into the handle.The loose head would cause the hex not to engage properly.After this, when the knob was rotated an inserted blade would rotate.The driver was then tested with a blade, a screw, and poplar.The blade could be successfully inserted into the driver.The screw was inserted and removed from the poplar with no issues.The complaint is confirmed as upon receipt, the driver would not turn a blade.The most likely underlying cause of the complaint is loosening of the head from the handle.
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Manufacturer Narrative
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This report was submitted to correct the device product code and 510(k) number.The following sections were corrected: device product code: jey corrected to hrs.Pma/510(k) number: k121589 corrected to k142823.
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Event Description
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This follow-up report is being submitted to relay corrected and additional information.
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Search Alerts/Recalls
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