WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH
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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 Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the usa as follows: it was reported that on an unknown date, the item tip was found broken.There was no patient outcome/consequences.It is unknown when the issue was observed.It is unknown if there is patient involvement.This complaint involves one (1) device depth gauge for 2.7mm & small screws.This is report 1 of 1 for complaint (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: d9 h3, h6: a product investigation was conducted.Service and repair evaluation: the customer reported the item tip was found broken.The repair technician reported broken tip.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The item will be forwarded to customer quality.The evaluation was confirmed.H3, h6: a device history record (dhr) review was conducted: part # 319.04 synthes lot # 5581501.Supplier lot # 5581501.Release to warehouse date: 21 aug 2007.Manufacturing location: (b)(6).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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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