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Device Problems
Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problems
Foreign Body In Patient (2687); No Code Available (3191)
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Event Date 12/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown expert tibial nail/unknown lot.Part and lot number are unknown; udi number is unknown.It is unknown if the complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 (b)(6) reports an event as follows: it was reported that on an unknown date, during an adolescent lateral femoral nail (alfn) removal, the extraction screw for tibial and femoral nail broke by shedding the threads of the extraction screw.The tibial nail was not able to be removed.Neither the extraction screw for tibial and femoral nail, alfn extraction screw nor the ipswich system could attach to the tibial nail to removed it indicating the threads in the nail could be damaged.The reason for the revision was noted to be scars, but the reason for the removal of the nail is unknown; however, it was confirmed there was no infection.It was noted the nail remained in the patient but there was no patient harm due to it; the patient condition is reported as stable.Another surgery to remove the nail is not planned at this time.This report is for an unknown expert tibial nail.This is report 3 of 4 for (b)(4).
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Event Description
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Procedure occurred on (b)(6), 2018.
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Manufacturer Narrative
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: corrected data: initial reporter name and address: country code.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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