Catalog Number 03.221.007 |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported that the cable cutter is missing a screw.This report is 1 of 1 for (b)(4).
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Event Description
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The extraction screw is having a threading problem.
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Manufacturer Narrative
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Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the device history records has been requested.Device used for treatment, not diagnosis.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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Manufacturer Narrative
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Additional narrative: subject device has been received and is currently in the evaluation process.A device history review was conducted.The report indicates that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material which was delivered as lot #712004 is corresponding to the specifications.The hardness was measured at the time of the manufacturing between 45-47,5 hrc and was found to be good.Device was used for treatment, not diagnosis.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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Manufacturer Narrative
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Additional narrative: a product investigation was completed: the cable cutter with trigger is one of three devices able to be used to cut cables in the orthopaedic cable system.The three potential cutters which can be used to cut cables include the standard cable cutter (391.905), the large cable cutter (391.906), and the cable cutter with trigger handle.The blade for cable cutter (03.221.008) was also returned but the complaint was specific to part (03.221.007).The returned cable cutter with trigger handle was manufactured on november 16, 2011.The relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.The returned device was received disassembled with the m4 shoulder bolt missing.The m4 shoulder bolt and nut mate with each other in the trigger handle to serve as a hinge and ensure that the trigger remains attached to the body of the trigger handle.Based on the available information it is not possible to determine an accurate root cause for the complaint condition.Upon inspection of the m4 shoulder nut which was returned, neither the exterior of the nut nor the inner threading which interacts with the m4 shoulder bolt indicated any damage which would contribute to the complaint condition.It is possible that the missing m4 shoulder bolt was lost during sterile processing after the device was disassembled and not properly re-assembled post sterilization with all the essential components.Device was used for treatment, not diagnosis.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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Search Alerts/Recalls
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