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Model Number 279702030 |
Device Problems
Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: 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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the hospital has put aside various expedium instruments that were starting to show wear and tear from long term use.The instruments were taken from sets and out of circulation if deemed no longer usable due to bends, breakage, malformation, stripping etc.There have been no adverse events or impact to the patient with these instruments.This report involves one (1) expedium spine system thoracic pedicle probe, str.10-50mm plus or minus 4.00 percent.This is report 3 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9 h3, h6: a product investigation was conducted.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 xpdm thoracic pedicle prb, st was bent at the tip.A dimensional inspection for the xpdm thoracic pedicle prb, st 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 mentioned in the event description.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 xpdm thoracic pedicle prb, st 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.A review of the receiving inspection (ri) for xpdm thoracic pedicle prb, st was conducted identifying that lot number nw212641was released in four batch.Part # 279702030.Lot # nw212641.Supplier: norwood medical ¿ batch1: lot qty of 282 units were released on may 9, 2018 with no discrepancies.No ncrs were generated during production.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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Search Alerts/Recalls
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