MEDOS INTERNATIONAL SÃ RL CH 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
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2021 |
Event Type
malfunction
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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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 during the cleaning process it was discovered that the approximator was jammed and the screwdriver had been stripped.This report is for one (1) expedium spine system clip-on red.Driver w/dovetail 5.5mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This complaint is confirmed as the reduction tip was jammed and would not rotate.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot: a review of the receiving inspection (ri) for approximator fc sleeve was conducted identifying that lot number nw255832 was released in a single batch.Batch1: lot qty of units were released on 29 may 2020 with no discrepancies.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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