WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE, DEPTH
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Model Number 319.091 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 on unknown date that there was an issue with the tfna lag screw inserter and we wanted to replace helical blade and screw coupling screw as these pieces work together to insert the screw.Both of the inserters have a combination of issues.When trying to load the screw, we need to push extremely hard for the screw to seat and be screwed in properly.There is no further information.Concomitant device: unknown nail distal locking screw (part# unknown, lot# unknown, quantity #unknown).This report is for one (1) depth gauge for 3.5mm cortex screws.This is report 1 of 2 for complaint: (b)(4).
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Event Description
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It was further reported that the tips of the depth gauges broke off.This is report 5 of 6 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5, d7a, g1.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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