Device Problem
Use of Device Problem (1670)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 10/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unk - drill bits: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Without a lot number the device history records review could not be completed.Product was not returned.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for femoral neck fracture with the fns and the drill bit in question.During the surgery, the surgeon measured the bolt length and it appeared 83mm.The surgeon chose an 85mm bolt.After the surgeon inserted the 85mm bolt, he set the drill bit for 85mm to drill the anti-rotation screw hole.During the drilling, the drill bit stopped about 15mm before the tip of the neck bolt.The drill bit was set for 85mm certainly, and the stopper of the drill bit was in contact with the device.The surgeon drilled with the drill bit which was set for 95mm, and he tried to insert a 95mm anti-rotation screw, but the 95mm anti-rotation screw was too long to insert fully.The surgeon inserted an 85mm anti-rotation screw, and the surgery was completed successfully.The surgery was delayed by less than 30-minutes.It took 5-minutes to replace the anti-rotation screw.The plate lifted about 5mm from bone, but the surgeon loosened the screw of the device, and the event was improved by using the telescoping of the plate.Concomitant medical products: unk - depth gauges (part# unknown, lot# unknown, quantity 1), unk- fns antirotation screw (part# unknown, lot# unknown, quantity 1), unk - screws: locking (part# unknown, lot# unknown, quantity# 1), unk - nail head elements: fns bolt (part# unknown, lot# unknown, quantity# 1), unk - plate (part# unknown, lot# unknown, quantity# 1).This report is for 2 of 2 for (b)(4).
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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.The complained pictures were forwarded to the medical safety officer for evaluation.Here the statement.In short i can¿t confirm this unless we get that drill back.The x-rays look good.Here is my interpretation of this.The ars drill bit set for 85 mm indeed went to the correct depth.The ars and drill bit by design end up mm¿s short of the bolt depth and maybe the thought was it was to go to the same depth.So, i think they thought it was to be deeper.I would be interested in this surgeons fns experience.Otherwise the only other explanation is that the ars drill bit is indeed nonconforming and 5-10 mm short or the laser marks are off by that amount.There is no doubt the setting on the stop is correct at 85 mm.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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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.H6: patient code 3191 used to capture additional medical/surgical intervention required.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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Updated concomitant devices reported: depth gauges (part#unknown, lot#unknown, quantity 1), fns antirotation screw (part# 04.168.495, lot# l565550, quantity 1), screws: locking (part# unknown, lot# unknown, quantity# 1), nail head elements: fns bolt (part# unknown, lot# unknown, quantity# 1), plate (part# unknown, lot# unknown, quantity# 1).
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Search Alerts/Recalls
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