SMITH & NEPHEW, INC. UNIV CAN ACET SCREW 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71336530 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
Event Type
malfunction
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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 a thr surgery, the univ can acet screw 30mm device was found to be delaminated at the end of its insertion in the acetabular cup, it was removed and another s+n back-up screw of the same size was placed.The procedure was resumed, after a non-significant delay.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include user/procedural variance and/or mishandling during surgery.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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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Manufacturer Narrative
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The associated device was returned and evaluated.The visual inspection revealed the material encircling the screw head has experienced breakage.The visual also reveals that there was damage on the thread on the body of the screw.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique and/or excessive forces.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 for future complaints and investigate as necessary.We consider this investigation closed.
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