(b)(4).Investigation summary: the device associated with this report was received for investigation.Visual examination of the device denoted that that the fixed lever part of the rotation lever and spring assembly is broken.This lever is the opposite spring fixation point and due to breakage, spring fell out from the assembly.The spring was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint # (b)(4).Investigation summary: the device associated with this report was received for investigation.Visual examination of the device denoted that the fixed lever part of the rotation lever and spring assembly are broken.This lever is the opposite spring fixation point and due to breakage, spring fell out from the assembly.The spring was not returned for examination depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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