Model Number 03.620.061 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that on an unknown date, during evaluation at service and repair, it was found that the 10nm torq limiting ratchet handl-6mm hxc had failed in calibration.There was no patient involvement.This report involves one 10nm torque limiting ratchet handle-6mm hxc.This is report 1 of 1 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.Reporter is a j&j employee.The device was received, the investigation is in progress, 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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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.H3, h6: part 03.620.061, synthes lot: 1977180507, supplier lot: 1977180507, release to warehouse date: 09 june 2022, supplier: (b)(4).No nonconformance reports (ncrs) 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.Service and repair evaluation: during evaluation at service and repair it was found out that the 10nm torq limiting ratchet handl-6mm hxc had failed in calibration.The repair technician reported device failed torque testing and was out of calibration, the device required further testing at the vendor.The cause of the issue is torque failed high.The vendor reported that the maximum torque peak attained during evaluation was out of the specified limit for the part.Torque test high is the reason for repair.The item will be repaired and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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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