Catalog Number LSBK1-AX-06 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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An internal complaint investigation was performed for this issue.Specifically, a historical complaints review was completed for the alleged deficiency "broken anchor bolts".There have been 13 similar complaints for anchor bolts breaking between january 1, 2017 and march 18, 2019.A capa and investigation review was also conducted for the alleged deficiency "anchor bolt broke during implantation" and there have been no capas or investigations opened for this issue to date.A batch record review was conducted; (b)(4) lsbk1-ax-06 anchor bolts were planned for this work order and (b)(4) were completed.No issues were noted in the work order process notes that would contribute to the reported complaint.All (b)(4) lsbk1-ax-06 anchor bolts passed the in-process and final qc checks.No product return analysis could be performed for this complaint as no product was returned.According to the customer's sales representative, the patient's skull was thicker and required more force to place the bolt.The neurosurgeon was more aggressive when attempting to insert (i.E., screw in) this bolt into the skull; thus resulting in the bolt snapping.The risk level for this issue remains alap (as low as possible).Additionally, based on a review of previous complaints for anchor bolt breakages and an analysis of all anchor bolt breakage complaint data, the current rate of anchor bolt breakage complaints versus products sold is very low; (b)(4) over the past 2 years.Ad-tech is continuing to monitor this issue closely.
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Event Description
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On march 15, 2019, ad-tech received a copy of a medwatch 3500a report from the food and drug administration (fda).The report was from a user facility (uf), documented under uf report # (b)(4).According to the form, it was stated that, ".When inserting the anchor bolt, the bolt snapped." part of the bolt remained in the skull and a needle driver was used to secure the anchor bolt, thus enabling the bolt to be unscrewed for removal.According to the user facility, they were not aware of any other information about the patient that may have influenced the outcome of the event.
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Search Alerts/Recalls
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