OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Pma/510k: this report is for an unknown nail head elements: tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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 (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery using the tfna implants.During the surgery, the surgeon connected the impactor to the guide sleeve and tried to insert the blade, but he could not insert it completely.He tried to insert the blade by hitting the guide sleeve with a hammer, but he was unsuccessful.He removed the blade and inserted it without the guide sleeve and applied the locking mechanism.The surgery was successfully completed with a less-than-30-minute delay.The patient outcome was reported as stable.After the surgery, the surgeon confirmed that the entry part of the blade had been deformed, but it was unknown when it had been deformed.No further information is available.This report is for one (1) unk - nail head elements: tfna helical blade.This is report 1 of 4 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.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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