SYNTHES GMBH TFNA FENESTRATED SCREW 105MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
|
Back to Search Results |
|
Catalog Number 04.038.205S |
Device Problems
Break (1069); No Apparent Adverse Event (3189)
|
Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional device product codes: hsb.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient¿s nail broke.The patient experienced pain in (b)(6) 2021.A scan was performed on (b)(6) 2021 and the broken nail was discovered at the level of the cephalic screw.On (b)(6) 2021 the patient underwent a revision surgery, the nail was removed and a hip arthroplasty was performed.This report involves one (1) tfna fenestrated screw 105mm - sterile.This is report 3 of 3 for (b)(4).
|
|
Event Description
|
The patient was reported as good.
|
|
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.
|
|
Event Description
|
It was confirmed that the break occurred to the nail and not to the other devices so the complaint is only on the nail and there is no allegation against the device tfna fenestrated screw 105mm - sterile.
|
|
Search Alerts/Recalls
|
|
|