Catalog Number 03.615.460 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in the (b)(6) as follows: it was reported that an unknown date, after a procedure, it was noticed that part of the retractor blade was broken.The patient was sent for x-rays a day after the procedure and no fragments were visible in the x-ray.The procedure was completed successfully.Concomitant devices reported: blade cranial/caudal le l60 (part number 03.615.360, lot unknown, quantity 1).This report involves one (1) retractor blade 60mm cranial/caudal-right.This is report 2 of 2 for (b)(4).
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Event Description
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Concomitant device reported: blade cranial/caudal le l60 (part number 03.615.360, lot t951375, quantity 1).
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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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