SMITH & NEPHEW, INC. ANTHOLOGY INSERTER ANT SOFT; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
|
Back to Search Results |
|
Model Number 71365721 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/08/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the anthology inserter ant soft broke in case.It is unknown when the event happened and if there was a patient involved.
|
|
Event Description
|
It was reported that, during surgery the anthology inserter ant soft broke inside the patient.There was no delays in the procedure and all the pieces were retrieved from the patient.No other complications were reported.
|
|
Manufacturer Narrative
|
Internal complaint reference number: (b)(4).
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was broken along the tip, rendering the device inoperative.The broken components were not returned.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|