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Catalog Number 472.265S |
Device Problem
Failure to Align (2522)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient weight is unknown.(b)(4).Complainant part is not going to be returned.Concomitant devices reported: blade (unknown part #, unknown lot #, quantity of 1).Aiming arm (unknown part #, unknown lot #, quantity of 1).Insertion handle: (unknown part #, unknown lot #, quantity of 1).(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the usa.A review of the device history record was performed and no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Based on the complaint description, without material, no further investigation is possible.Per dhr review of the known lot numbers were the parts manufactured according to the specification.We can only declare that for the products 472.265s and 459.420 we use only raw material which corresponds the astm f1295 specification and the international standards iso 5832-11.(b)(4).We are not aware of any quality problems or failures caused by a faulty product on the article.Also we are not aware of any other complaint for this article- and lot number combination.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 europe reports an event in (b)(6) as follows: it was reported by the surgeon that a 4.9 locking bolt missed the aperture in the nail.This was discovered on (b)(6) 2016 during post-op lateral view x-rays that were taken 3 days after proximal femoral nail antirotation (pfna) surgery.In the surgeon's opinion, he states that this probably occurred due to the small diameter of nail which was too small for the patient's anatomy.In addition, excessive force may have been placed on insertion handle/aiming arm during drilling of distal locking bolt causing drill and locking bolt to skive and miss the nail.Original implant date occurred on (b)(6) 2016.Surgeon revised the nail successfully on (b)(6) 2016.Concomitant devices reported: blade (unknown part #, unknown lot #, quantity of 1), aiming arm (unknown part #, unknown lot #, quantity of 1), insertion handle: (unknown part #, unknown lot #, quantity of 1).This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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