SMITH & NEPHEW, INC. BOX CHISEL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71440373 |
Device Problems
Fracture (1260); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka surgery, metal in a box chisel was chipped so it gets stuck in a jrn ii bcs box prep gd sz3-5.The procedure was resumed, without any delay, using the same device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
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Manufacturer Narrative
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H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned box chisel reveals multiple scratches, burrs, deep gouges and some pieces chipped off in the metal.The visual of the femoral prep guide reveals multiple scratches, burrs, deep gouges.These devices show signs of significant wear and use.A functional reveals the box chisel is jamming when connected to the femoral prep guide.The devices are difficult to separate once connected.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.These devices are reusable instruments 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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