SMITH & NEPHEW, INC. HEFTY BITE PIN CUTTER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number 210272 |
Device Problems
Break (1069); Degraded (1153)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during field inspection, it was discovered that a hefty bite pin cutter is chipping at the tip and is worn.No case involved; therefore, there was no patient involvement.
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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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The associated complaint device was returned for evaluation.A visual inspection of the returned device confirms the tip is chipping, rendering the device inoperable.The pieces that chipped off, were not returned with the device.This instrument exhibits signs of extreme wear and use.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.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.As the device broke and it can no longer fit its purpose, the 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.
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