WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 13X10X10MM; STAPLE, FIXATION, BONE
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Model Number SE-1310 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a 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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It was reported that on an unknown date, during a procedure, the staple fell off of the inserter prior to insertion.The procedure was successfully completed with no surgical delay reported.No patient consequence.This report is for a staple.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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