Catalog Number 292.620 |
Device Problem
Break (1069)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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Event Date 05/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(4).Device broke intraoperative not implanted of explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported that during an osteosynthesis for left bimalleolar fracture, two threaded steel wires for cannulated screws broke off.A broken off piece remained in the patients left tibia.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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(b)(6).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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Event Description
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Update 22sep2016: the parts of the guide wires are inside the patient's bone, the remaining parts have been discarded.Unknown if there was no patient harm, except or the piece left in the patient.Unknown if procedure was successfully completed.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Serious injury determined on (b)(6) 2016 corrected data: x-rays were taken but not available for investigation review.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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