Catalog Number 4999-1028,4999-1027 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product review/investigation could not be performed since product was not returned.Device history record review could not be performed, part and lot numbers were not provided.Root cause is unknown.No patient complications were reported.If additional information is obtained which changes the outcome of the investigation, a follow-up report will be filed.
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Event Description
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It was reported during a surgery using the axi+line proximal bunion correction system that the drill bit became jammed in the drill guide and essentially become welded in the guide.Additionally, the surgeon had to open a second axi+line kit because the driver did not adequately grip the screws.There were no patient complications reported, or delay of surgery.It was reported the user of the drill was a junior resident.
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Manufacturer Narrative
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This is a followup report to 3009540749-2020-00039, sections with no updates were left blank as per 21cfr803 sec 803.56 (c).The drill bit and drill guide were returned and received on 30 nov 2020 the driver was not returned.A review / investigation was performed on the returned drill bit and drill guide and it was concluded they met specifications for the dimensions which were able to be verified.Device history record review for the drill bit and drill guide found no related non-conformances and the documentation shows no evidence of abnormalities.Root cause remains unknown.If additional information is obtained which changes the outcome of the investigation results, a followup report will be submitted.
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Event Description
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This report is a followup to 3009540749-2020-00039 which was submitted on 25 nov 2020.
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Search Alerts/Recalls
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