|
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problems
Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)
|
Event Date 11/06/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unknown plate.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 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.(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.
|
|
Event Description
|
It was reported that the patient underwent a removal surgery on an unknown date.On (b)(6) 2017, the patient underwent open reduction and internal fixation (orif) of her left wrist.After 1 of her sessions of physical therapy, the patient had significant increase of swelling and pain.Upon review of radiographs, it did appear that 1 of the screws had backed out of the plate a little bit.There was a removal of a loosened screw due to possible injury and irritation of tendons.This complaint involves two (2) devices.This 1 of 2 for report (b)(4).
|
|
Manufacturer Narrative
|
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.The x-ray shows a unknown distal radius plate.The x-ray is in poor quality and just in one plane, which makes it hard to make a clear conclusion.It appears that the distal screw on the left side is backed out as complained, therefore is the complaint rated confirmed.Product was not returned and no article- and lot number was provided, therefore no further evaluation is possible.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.
|
|
Manufacturer Narrative
|
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.Pma\510k: awareness date reported on follow up 1 report as october 22, 2019 but should have been november 22, 2019.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.
|
|
Event Description
|
It was reported that the patient underwent a removal surgery on (b)(6) 2017.After 1 of her sessions of physical therapy, the patient had significant increase of swelling and pain.Upon review of radiographs, it did appear that 1 of the screws had backed out of the plate a little bit.There was a removal of a loosened screw due to possible injury and irritation of tendons.On (b)(6) 2017, the patient underwent open reduction, internal fixation left comminuted distal radius fracture greater than three parts using volar plating.A three hole volar locking plate from synthes was placed over the volar aspect of the fracture fragments locking the fracture fragments underneath of the fracture.This complaint involves two (2) devices.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|