SMITH & NEPHEW, INC. GII SPC P/S HOUS COLLET S 3-8; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440001 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Event Description
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It was reported that, during a tka surgery, a genesis ii symmetrical posterior condyles fixed posterior stabilized housing collet size 3-8 broke while being removed from trial.As reported, the instrument broke while outside the patient.It is unknown if any pieces fell inside the patient.It is unknown how the procedure was completed.No delay or harm to the patient was reported as a consequence of this problem.
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Event Description
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It was reported that, during a tka surgery, a genesis ii symmetrical posterior condyles fixed posterior stabilized housing collet size 3-8 broke while being removed from trial.As reported, the instrument broke while outside the patient.No pieces fell inside the patient.Surgery was performed, without any delay, with the same device.
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Manufacturer Narrative
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Internal reference number: (b)(4).
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Manufacturer Narrative
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Section h3, h6: a visual inspection of the returned device confirmed the stated failure mode.One of the knob and spring mechanism is broken and separated from the device, rendering it inoperative.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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Due to the need for a backup device, a contribution of the device to the reported event could be corroborated.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.E1: initial reporter name and adrress/ name prefix or title.
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