SYNTHES USA 2.7MM CANNULATED DRILL BIT/QC 160MM; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
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Catalog Number 310.670 |
Device Problems
Overheating of Device (1437); Dull, Blunt (2407)
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Patient Problem
Burn(s) (1757)
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Event Date 12/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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Additional product codes: gfa, gff, hsz.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that two threaded needles broke in the patient foot bone due to issues with the kirschener wire attachment and the drill attachment.The broken devices remained in the patient and it was noted that the devices also overheated and burned the patient¿s bone.There was an increase in surgical time by twenty (20) minutes.It was noted that the drill bit did not have cutting edge; this drill was completely rusted and uncut and had been used several times.The procedure was completed with spare non-synthes power tool equipment.There was no intervention to try to remove the broken devices from the patient¿s bone.The patient¿s current status is unknown.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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A product investigation was completed: the complained parts were not returned for investigation so an investigation was completed on the provided pictures.According to received pictures, both k-wires (part 292.620) were broken.The attachment was not able to hold the k-wire properly, which most probable caused breakage of the wires.The root cause of the problem is improper handling.The device has not been annually serviced and the device history record and service history record review does not reveal any relevance to the current complaint condition.According to received pictures, a lot of signs of the corrosion are visible on the drill bit (part 310.670) and the cutting edges do not exist anymore.Most probable the drill bit was already worn (used too many times) and incorrectly reprocessed.Cutting tools are frequently exposed to high mechanical loads and shocks during use and should not be expected to last indefinitely.Using worn out cutting tools like the reported one generates a lot of heat.The root cause of the problem is normal wear and improper reprocessing, the device has not been annually serviced and the device history record and service history record review does not reveal any relevance to the current complaint condition.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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