Catalog Number 03.607.009 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information is not available for reporting.Udi: (b)(4).Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter's telephone: (b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6)2017, the rod introduction pliers broke.All fragments were retrieved.Surgery was completed successfully with a delay of approximately one (1) hour.No patient harm was reported.Concomitant devices reported: wire (part number unknown, lot number unknown, quantity 1).This report is for one (1) rod introduction pliers for uss polyaxial.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device history records review was completed for part# 3.607.009, lot# 8929293.Manufacturing location: (b)(4), manufacturing date: may 22, 2014.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing evaluation was completed.The visual inspection shows that the device is in a used condition and visible damages and deformations were observed.The review of the production history revealed that this uss-ii polyaxial rod instruction pliers was manufactured in may 2014 per the specifications.No manufacturing related issue that would have contributed to this complaint were found.The device has been tested with the functional gages.During opening and closing unsmooth running was observed because of the damages and deformation of the plier.This damages and unsmooth running of the plier has no impact on important product functionality.No production failure has been found.This complaint is not confirmed.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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Date received by manufacturer was inadvertently reported as aug 18, 2017 in mw-459601.The correct date is sep 12, 2017.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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