Catalog Number 319.100 |
Device Problem
Incorrect Measurement (1383)
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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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Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing location: (b)(4).Manufacturing date: january 29, 2015.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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 europe reports an event in (b)(6) as follows: it was reported that there were concerns with the readings on the gauge at extremity of the gauge.The measurement of the extremity of the gauge reads 20mm while the gauge provides a 25mm length.This occurred with four devices.No information about patient condition was provided.This is report 1 of 4 for (b)(4).
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Manufacturer Narrative
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The initial complaint was reviewed and found not reportable.Additional information received indicates the gauges mentioned in this complaint were not used, and still in the sealed packaging.The information in this complaint record does not suggest that a device malfunction occurred.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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The initial complaint was reviewed and found not reportable.Additional information received indicates the gauges mentioned in this complaint were not used, and still in the sealed packaging.The information in this complaint record does not suggest that a device malfunction occurred.
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Search Alerts/Recalls
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