WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI DISTAL EXTENSION SIZE 3/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT
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Model Number 04.641.113 |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 06/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.Date of event is unknown.Lot number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address are unknown.Reporter is a synthes employee.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.(b)(4).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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(b)(6) reports that during an unknown procedure on an unknown date, the titanium (ti) rod broke when it was bent to be used and thus, was not implanted.A second rod, which was slightly larger, was used in the procedure, and the tail end had to be cut off.Surgical outcome is unknown.There was no surgical delay.There is no reported patient consequence.This report is for a ti distal extension size 3/220mm radius.This is report 1 of 1 for (b)(4).
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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.Date of event is now known.Additional information provided.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 event occurred during a lengthening of the vertical expandable prosthetic titanium rib (veptr) rod procedure on (b)(6) 2018.Procedure was completed successfully.
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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.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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