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DEPUY SPINE INC EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
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| Model Number 279712580 |
| Device Problem
Device-Device Incompatibility (2919)
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| Patient Problem
No Code Available (3191)
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| Event Date 03/17/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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) 2020, during a type c spinal injury procedure, the reduction instrument could not be loosened from the clip.The pedicle screw ripped off after the rod was connected.The left side had to be loosened completely and a thicker screw had to be put in place.The procedure was successfully completed with a one (1) hour surgical delay.There was no patient consequence.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity 1), approximator flex-clip (part # 279712570, lot # unknown, quantity 1), unknown rod (part# unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity 1).This report is for one (1) expedium spine system clip-on red.Driver w/dovetail 5.5mm.This is report 3 of 4 for (b)(4).
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Event Description
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Concomitant device reported: approximator flex-clip (part# 279712570, lot# nw154765, quantity 1).Approximator flex-clip (part# 279712570, lot# nw141902, quantity 1).Approximator flex-clip (part# 279712570, lot# nw211054, quantity 1).Approximator flex-clip (part# 279712570, lot# nw233004, quantity 1).Approximator flex-clip (part# 279712570, lot# nw154764, quantity 1).Approximator flex-clip (part# 279712570, lot# nw154765, quantity 1).Approximator flex-clip (part# 279712570, lot# nw215534, quantity 1).Concomitant device reported: approximator fc sleeve (part# 279712580, lot# nw215553, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw121892, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw219500 , quantity 1) approximator fc sleeve (part# 279712580, lot# nw138525, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw153355, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw137404, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw219497, quantity 1).Concomitant device reported: approximator fc inserter (part# 279712590, lot# nw147159, quantity 1).Approximator fc inserter (part# 279712590, lot# nw153412, quantity 1).Approximator fc inserter (part# 279712590, lot# nw219408, quantity 1).Approximator fc inserter (part# 279712590, lot# nw121905, quantity 2).Approximator fc inserter (part# 279712590, lot# nw212280, quantity 1).Approximator fc inserter (part# 279712590, lot# nw138440, quantity 1).Approximator fc inserter (part# 279712590, lot# nw121905, quantity 1).
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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.H10 additional narrative: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: a review of the receiving inspection (ri) for approximator fc sleeve was conducted identifying that lot number nw215553 was released in a single batch.Batch1: released on april 30, 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual insopection: approximator flex-clip and approximator fc sleeve were received in assembled condition.Both devices were found stuck/ locked, it was unable to disassemble them.The complaint is confirmed.Functional testing: approximator fc sleeve was unable to disassemble mating device.Dimensional inspection: the dimension inspection could not be performed due to received stuck condition of the devices.Conclusion: the exact cause is unknown.It is possible that rough handling during use and/or processing could have contributed to the complaint condition.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H11 corrected data: d4 lot.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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