SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 71363077 |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/18/2022 |
Event Type
Injury
|
Event Description
|
It was reported that, r3 offset impactor tip broke while impacting the shell.All pieces were removed from patient.The mechanism of locking the shell down failed when impacting.Device inside the patient.The procedure was completed using a s+n back-up device.Surgery was less than or equal to 30mins delayed.Patient was not harmed.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Event Description
|
It was reported that, r3 offset impactor tip broke while impacting the shell.All pieces were removed from patient.The mechanism of locking the shell down failed when impacting.Device inside the patient.The procedure was completed using a s+n back-up device.Surgery was less than or equal to 30mins delayed.Patient was not harmed.
|
|
Manufacturer Narrative
|
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, all pieces form the broken r3 offset impactor tip were removed from patient.Based on the limited information provided the root cause of the reported impactor tip breakage could not be determined.The procedure was completed using a s+n back-up device.No patient injuries or adverse consequences were reported.No further medical assessment can be rendered at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|