WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH
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Catalog Number 319.006 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2021 |
Event Type
malfunction
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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 (b)(6) 2021, it was noticed that old style gauges found in distal radius/mod mini frag lcp/va midfoot set, etc.Are functionally bend, break, and become loose easily and have a short lifespan.There was no patient harm or procedure reported.This complaint involves five (5) devices.This report is for (1) depth gauge for 2.0mm and 2.4mm screws.This report is 1 of 5 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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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Search Alerts/Recalls
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