Catalog Number 03.501.080 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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There was no known reported patient involvement associated with the complained event.Date of event is unknown.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part number 03.501.080, lot number 8209190: manufacturing location: (b)(6), manufacturing date: 14.Dec.2012: no non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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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It was reported that the trigger doesn't retract on an application instrument for sternal zipfix.The device does not completely tension/tighten full cycle.No patient or surgery involvement.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Service history review: no service history review can be performed as part number 03.501.080 with lot number(s) 8209190 is a lot/batch controlled item.The manufacture date of this item is 19-dec-2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A service and repair evaluation was performed on the returned subject device: the customer reported the trigger did not retract.The repair technician reported the handle screw was loose, and the torque retaining nut was loose.Loose component is the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, passed synthes final inspection on 7-jun-2017 and will be returned to the customer upon completion of the service and repair process.The evaluation was 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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Search Alerts/Recalls
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