|
Model Number 04.503.212.01 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/24/2022 |
Event Type
malfunction
|
Event Description
|
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, surgeon's nursing assistant attempted to remove midface screws for an endobrow patient in private room using incorrect driver shaft and handle.The screw heads sheared off.Fragments were generated but were removed easily.Surgeon was called to room to retrieve using long needle holders.There was unspecified amount of surgical delay due to the reported event.No patient consequence reported.The procedure was completed successfully.This report is for one (1) ti matrixmidface screw self-tapping 12mm.This is report 2 of 2 for complaint (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.Additional device product code: hwc.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.
|
|
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.H10 additional narrative: h6: a device history record (dhr) review was conducted: part #: 04.503.212.01s, lot #: 763p703, manufacturing site: jabil bettlach, release to warehouse date: 19, april 2022, expiry date: 01, april 2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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
|
|
|