Catalog Number 351.019 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided for reporting.Gtin unavailable, product made prior to gtin compliance date.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review has been requested.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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It was reported that during an unknown case on (b)(6) 2018 the tip of the awl broke.The tip of the broken device was retrieved from the patient.It is unknown if there was a surgical delay.Patient outcome was unknown.The surgery was completed.This report is for one (1) medium awl for flexible humeral nail.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: a device history record (dhr) review was conducted for part # 351.019, synthes lot # 4663868: supplier lot # na, release to warehouse date: 30dec2003, manufactured by synthes brandywine: material review record (mrr) was generated during production for qty 1 nick on blade during visual inspection.The product was dispositioned as conforms to specification as of 29dec2003.Mrr was generated during production for uneven surface finish qty 4.Qty 4 scraped as of 22dec2003.Mrr was generated during production for packaged with incorrect tip guard, qty 8 the product was dispositioned as qty 8, use as is as of 29dec2003.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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