SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 75007308 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, during thr surgery, the sl-plus/sbg/ipa mia offset adapter 40mm was broken.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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Event Description
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It was reported that, during thr surgery, the sl-plus/sbg/ipa mia offset adapter 40mm was broken.The male adaptor to the strike handle broke, during use in the patient.The broken handle was removed per usual exchange of broaches, a send handle was used.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: it was reported that, during total hip replacement surgery, the sl-plus/sbg/ipa mia offset adapter 40mm was broken.The male adaptor to the strike handle broke, during use in the patient.The broken handle was removed per usual exchange of broaches, a send handle was used.No injury was reported as a consequence of this issue.The complaint device was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the clutch is fractured at the distal end.All fragments were returned.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed 2 additional similar complaints reported for the same batch, and 3 additional similar complaints for the same product number over the past 12 months with similar failure mode.Previous investigations revealed that under specific circumstances, the clutch of the device may fracture while hitting.The root cause is attributed to a design issue.A new design of the device has been released in order to reduce the reoccurrence of this issue.This version of the device will be monitored for similar issues.The performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product.No further escalation is required.Please note that according to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Furthermore, in the instrument sets of smith & nephew orthopaedics ag, there is always at least one backup rasp adapter available.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.
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