MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 75MM; ORTHOSIS, SPINAL PEDICLE FIXATION
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Model Number 186727875 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2022 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in taiwan as follows: it was reported that on (b)(6)2022, the nail was broken during use.There was a surgical delay of 90 minutes.There were no fragments generated.There were no patient consequences.The procedure was successfully completed.This report involves one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 8 x 75mm.This is report 1 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.Device available for evaluation: 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.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.H10 additional narrative: h3, h4, h6 investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the head screw of the mis ti cfx fen poly 8x75 was observed with several scratched and dented.The broken condition was not observed.A dimensional inspection for the mis ti cfx fen poly 8x75 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the mis ti cfx fen poly 8x75 would contribute to the complained device issue.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.Drawing/specifications reviewed: yes, conforms.Dimensional inspection: n/a.Device history: a manufacturing record evaluation was performed for the finished device.Product code: 186727875s, lot number: 317471, it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 18.08.2021 qty: (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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