Model Number 398.79 |
Device Problem
Break (1069)
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Patient Problems
Foreign Body In Patient (2687); No Code Available (3191)
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Event Date 01/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #(b)(4).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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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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Event Description
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It was reported that on (b)(6) 2020, the self-centering bone forcep broke off during surgery.Fragments were generated and was left in the patient.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.This complaint involves one (1) device.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: complaint is confirmed as we are able to confirm complaint description (broken) based on the received pictures.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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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Product complaint # (b)(4).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, h6: investigation summary complaint is confirmed as we are able to confirm complaint description (broken) based on the received pictures.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 (information or/and material), the investigation will be updated as applicable.,it was reported that on (b)(6) 2020, the self-centering bone forcep broke off during surgery.Fragments were generated and was left in the patient.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Flow: damage.Visual inspection: the instrument was received at us cq and upon inspection the portion of the distal jaw with the serrated teeth broke off and was not returned.No other issues were identified.A device failure was identified.Service and repair evaluation: the customer reported the device broke during surgery.The repair technician reported the jaw is broken, pieces are missing.Cutting jaws broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review: the following drawings were reviewed: bone forceps self centering with speed lock: 398_79 rev f.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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