Model Number 319.04 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 unknown date, products found broken after surgery and are beyond repair.No further information is available.This complaint involves eighteen (18) devices.This report is for (1) depth gauge for 2.7mm & small screws this report is 11 of 14 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a (b)(6) representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 unknown date, products found broken after surgery and are beyond repair.No further information is available.This complaint involves eighteen (18) devices.This report is for (1) depth gauge for 2.7mm & small screws this report is 11 of 14 for (b)(4).
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Search Alerts/Recalls
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