Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported a 90 degree screw driver came loose in a rib case.The screwdriver was being used to drive screws and the head seemed to come loose and start to turn and make it very difficult to use.Backup 90 degree screwdrivers were used to complete the surgery.There was no harm in the case and no delay.The case went well.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00542.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was not confirmed.The 90 degree contra angle screwdriver, part# 24-1189, lot# 008100 and lot# 191750, were visually evaluated.Both drivers showed signs of use with some minor discoloration.The drivers were functionally tested by driving a locking screw into a block of white oak wood, using a contra angle traumaone cross-drive blade.Both drivers were able to insert the screw into the block of white oak as intended, with minimal sticking during rotation of the knob.Device history records were reviewed and no discrepancies were found.There are no indications of manufacturing defects.The complaint was not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated:
a5 ethnicity
b4 date of this report
g4 date received by manufacturer
g7 type of report and follow-up number
h2 follow-up type
h3 device evaluated by manufacturer
h6 method code
h6 results code
h6 conclusions code
h10 additional narratives/data
multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00542-1.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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