Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.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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It was reported that patient was initially supposed to receive an anatomic total shoulder.In the process of preparing for the anatomic, a couple instruments broke.The version indicator broke when removing it from the humeral stem pathfinder.The grey plastic park cracked.Also the ring on the trial taper adapter broke off when removing it from the humeral head trial.The patient ended up needing to be converted from an anatomic to a reverse total shoulder.When converting it, surgeon told me the tip of the star driver 20 was stripped and needed to be replaced.He had some troubles in filling locking down the peripheral screws, but it wasn't quite bad enough to delay the case.There was no surgical delay.
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