SMITH & NEPHEW, INC. BOX CHISEL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440373 |
Device Problems
Material Fragmentation (1261); Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during tka procedure three box chisels were found dull.Metal shavings were discovered to have fallen into the patient.Suction was used to retrieve the metal shavings.The case was finished using instruments but they are badly worn and not usable anymore.A delay of less than 30 min was reported.
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Manufacturer Narrative
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The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is dull and has signs of wear and tear from use.This case reports that during a tka surgery, three box chisels were dull and metal shavings fell inside the patient.Per email correspondence, suction was used to retrieve metal shavings.The procedure was completed using a change in technique, with no harm to the patient and minimal delay.Therefore, no further clinical assessment is warranted.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.A review of risk management file found that the reported failure was documented appropriately.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.We consider this investigation closed.
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