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Catalog Number 26-1221 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Information (3190)
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Event Date 02/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation, a follow up report will be filed.
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Event Description
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The surgeon was trying to open a hole with the perforator on the skull, but it couldn¿t drill the bone well.The surgeon thought the coupling (attaching) with the drill device might be loose, so it was checked and re-attached for several times.However, the surgeon felt the same and the cutting performance was still poor.A manual tool was used instead and the surgery was completed.The same event happened for 2 times and the surgeon suspected that the product has a problem.It was confirmed that the perforator was not reused.There was no adverse consequence to the patient and no further information has been provided by the hospital.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the evaluation revealed the following: 1 perforator returned for evaluation.Lot number visible on label kj007s manufactured in october 2016 new bedford massachusetts facility.Adhesive sticking to product, outer part of label rubbed off.Perforator appears to have been used, visible signs of matter on inner and outer drill components.Drill was functionally tested 10x.Drill performance was acceptable all 10x.Outer drill and inner drill cutting angles were measured for each tine/flute with the following results (note, measurements are for reference only as angles can be changed by use and handling in the field): drill performance was not found defective.No cause can be found for the complaint.The device history records were reviewed and did not reveal any anomalies during the manufacturing process.Based on the results of this investigation, no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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Search Alerts/Recalls
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