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| Model Number 286725200 |
| Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
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| Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
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| Event Date 11/23/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot review of the receiving inspection (ri) for viper2 screw extension, closed was conducted identifying that lot number mi25950 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 17 dec 2012 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.Device history review.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 australia reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for revision surgery of second stage posterior fixation on a previously fixed l4/s1 anterior/lateral fixation where the l5 was slipping.During the surgery, surgeon was attempting to fuse, l4-s2ai posteriorly to reduce /fixate slip and decompress via mis approach and cement augmentation.However once reduction forces were put on the towers, the towers lost grip on the top notch of the viper 2 cfx screws causing them to disengage.This happened on multiple occasions (at least 4 different screw extension towers failed during primary attempts but at least 4 more failed in subsequent attempts.The rod was just sitting too far off the head of the screw to be able to get the reduction instruments to engage there threads and i don¿t think that the surgeon wanted to remove the rod completely to recontour the rod so that it would.Surgery was successfully completed with 90 minutes delay.The patient was recovering fine as per normal recovery timelines with no adverse effect noted due to extended op time, medication, anesthesia, or wound size (other than cosmetic).Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).Unknown rods (part# unknown, lot# unknown, quantity unknown).This complaint involves twelve (12) devices.This report is for (1) viper2 screw extension, closed.This report is 8 of 10 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.H10 additional narrative: b5: updated event description and concomitant devices 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.G3: the incorrect g3 date was inadvertently utilized in initial medwatch.The correct date is (b)(6) 2020.
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Event Description
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Device report from australia reports an event as follows: it was reported that on (b)(6) 2020 during a second stage posterior fixation on a previously fixed l4/5/s1 anterior/lateral fixation where the patients l5 was slipping, the surgeon was fusing the l4-s2ai posteriorly to reduce/fixate slip and decompress via a minimally invasive surgery (mis) approach with cement augmentation.The approach was to use viper 2 cfx screws l4-s1 and then viper sai screws into sacral iliac percutaneously with the aim to further enhance the fixation with cement augmentation l4-s1.The pedicles were successfully targeted using brainlab navigation and augmented screws using confidence cement under flouroscopy.The rod was inserted via the viper 2 extensions successfully.During the reduction of the rod into the heads of the screws using the viper 3d reduction instruments, the towers lost grip on the top notch of the viper 2 cfx screws causing them to disengage once reduction forces were put on the towers.This happened on multiple occasions, at least four (4) different screw extension towers failed during primary attempts and at least four (4) more failed in subsequent attempts.The disengagement happened on both sides (left and right of patient construct) and in both cases it happened on at least two screws.On the right side the towers disengaged from the l3 screw (viper2 6mm/40mm) and the l5 screw (viper2 6mm/50mm).On the left side the tower came away from the sai screw (viper sai 8mm/90mm) and from the l4 (viper2 6mm/45mm).The rod was unable to engage with the l4 screw on the left side and eventually this was explanted towards the end of the procedure and this level was skipped on the left side.Surgeon was forced to convert to mini open incision which increased incision exposure, increased blood loss and caused lengthy delays in the case length (increase of at least ninety (90) minutes).The procedure was completed successfully using a combination of additional instruments including resorting to using a competitive product.The patient is recovering fine.Concomitant devices reported: viper2 screw extension, closed (part # 286725200, lot # 0808mi, quantity 1), viper2 screw extension, closed (part # 286725200, lot # 0809mi, quantity 1), viper2 screw extension, closed (part # 286725200, lot # 0810mi, quantity 1), viper2 screw extension, closed (part # 286725200, lot # 1109mi, quantity 1), viper2 screw extension, closed (part # 286725200, lot # 1208mi, quantity 1), viper2 screw extension, closed (part # 286725200, lot # 1209mi, quantity 1), viper2 screw extension, closed (part # 286725200, lot # mi19173, quantity 1), mis ti cfx fen poly 6x40 (part # 186727640, lot # unknown, quantity 1), mis ti cfx fen poly 6x50 (part # 186727650, lot # unknown, quantity 1), unknown rods (part # unknown, lot # unknown, quantity unknown), viper ti sai poly 8x90mm (part # 179704890, lot # unknown, quantity 1), mis ti cfx fen poly 6x45 (part # 186727645, lot # unknown, 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h6: a product investigation was conducted.Visual inspection: the viper2 screw extension, closed (p/n: 286725200, lot #: mi25950) was returned and received at us cq.Upon visual inspection, scratches were observed on the device but have no impact on the device functionality.No other issues were observed on the returned device.Functional test: the overall functionality cannot be performed as the device was returned by itself.However, the inner sleeve component was not able to be compressed as intended due to internal components failure which could have lead to the complaint condition dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without the destruction of a device.Document/specification review since the exact date of manufacture of the device was unidentified, reflecting the current revision of the drawings were reviewed investigation conclusion the complaint condition was confirmed for the viper2 screw extension, closed (p/n: 286725200, lot #: mi25950).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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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Search Alerts/Recalls
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