SYNTHES GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED
|
Back to Search Results |
|
Catalog Number 03.503.476 |
Device Problems
Overheating of Device (1437); Material Deformation (2976)
|
Patient Problem
Burn(s) (1757)
|
Event Date 06/11/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.Device was used for treatment, not diagnosis.
|
|
Event Description
|
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the drill bit bent and caused burns to the patient.Two (2) other drill bits were tried and did not bend but heated to a point of causing the burns, upon inspection it seems that the drill sleeve has a slight bend in it.The procedure was completed successfully.This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 3 of 4 for (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.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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
|
|
|