SMITH & NEPHEW, INC. NONRIM SPEED PIN 65 STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Catalog Number 74013480 |
Device Problems
Fracture (1260); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a tka surgery, one (1) nonrim speed pin 65 sterile bent and got stuck inside of a tibial cutting guide three deg right.Burs were seen in a couple pin holes in the tibial cutting guide three deg right.Additionally, the tip of the nonrim speed pin 65 sterile broke off inside of a mis pin driver.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Event Description
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It was reported that, during a tka surgery, one (1) nonrim speed pin 65 sterile bent and got stuck inside of a tibial cutting guide three deg right.Additionally, the tip of the nonrim speed pin 65 sterile broke off inside of a mis pin driver.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
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Search Alerts/Recalls
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