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Catalog Number 05.001.080 |
Device Problems
Output below Specifications (3004); Intermittent Loss of Power (4016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The complete address of the manufacturing location is currently not available.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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It was reported from (b)(6) that the air pen drive device would not hold the power and was inconsistent.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.A visual and functional assessment was performed which determined that the motor had too little power, the device leaked, and the turning ring ran hard.During repair, an evaluation was performed, and it was determined that the device had a worn motor, an air leak, a jammed/seized knob, and a component damage.It was further observed that the device had an insufficient/low power and a cracked/damaged housing.It was further determined that the device failed pretest for check the adjustment sleeve, check power with power test bench, check speed with tachometer, check internal leak tightness and check external leak tightness.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Correction: d10: the date device returned to manufacturer was documented as june 9, 2020 in the initial report.This has been corrected to june 2, 2020.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.Correction: g1-2: the manufacturer location was incorrectly documented as depuy synthes supplier and the complete address of the manufacturing location was unknown in the initial report.The location has been updated to oberdorf.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.
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Search Alerts/Recalls
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