Catalog Number 201.928 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/09/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Device was not implanted/explanted.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the devices broke during surgery.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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Manufacturing investigation evaluation: the threaded shaft is completely broken off; the remaining portion measures approximately 4.6mm.The broken off, threaded shaft was not sent back for investigation.The microscopic investigation shows that the cruciform drive is moderately damaged.The tops of the cross slots have displaced metal in the clockwise and anti-clockwise direction relative to torque applied and presenting mechanical overload.The relevant dimensions at the fracture face of the screw were checked and found to be in compliance with the actual technical drawing and specifications.A final manufacturing conclusion cannot be presented because of product¿s condition and the unknown lot number.Visual investigation and comparing with the actual technical drawing indicates that the device met the specifications before the damage occurred.Based on the provided information, the exact cause of this occurrence cannot be determined.The appearance of the damage and fracture face indicates that a mechanical overloading situation (for example: exceptionally hard bone) caused the breakage of these screws.In this relation, the surgical technique mentions: in dense cortical bone, it may be necessary to predrill with a 1.5 mm drill bit.No manufacturing related issues were identified and/or confirmed.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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Search Alerts/Recalls
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