WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5 THREADED DRILL GUIDE DEPTH GAUGE; GUIDE, SURGICAL, INSTRUMENT
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Model Number 323.034 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) 2021, during an unknown procedure, the threads on the drill guides were worn out.They did not engage the threaded portion of the locking holes properly.No further information available.This report is for one (1) 1.5 threaded drill guide depth gauge.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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