SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71363077 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a thr, the r3 offset impactor tip broke upon impacting r3 cup.All fragments were located and retrieved.Surgery was performed, without any delay, with changing surgical technique.No patient complications were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the device broke into several pieces.All pieces were returned.The visual also reveals dried blood still on the device.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.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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.
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