SMITH & NEPHEW, INC. JRN II BCS LCK FEM IMPLANT IMPACT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 74012812 |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that during tka surgery, a screw was missing from a jrn ii bcs lck fem implant impact and other screw was loose.Impactor was still used but loose.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H6: medical device problem code.Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals two screws are missing from the device, causing one of the bumpers to come apart from the device.The screws were not returned.The device shows signs of extensive wear and use.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints 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.This device is a reusable instrument that can be exposed to numerous surgeries.Potential factors that may have contributed to the reported event include rough handling, misuse or misassembling after reprocessing.Additionally, 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.
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