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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)
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Event Date 02/11/2021 |
Event Type
Injury
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Event Description
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It was reported that on literature review "the pre-loaded set-screw in intertan nail: should it be tightened or not tightened in pertrochanteric hip fractures", one patient had an adverse event after being operated with an intertan nail fixation system due to a pertrochanteric hip fracture caused by a traffic accident.The patient's fracture was not healed at 2 years postop and the patient complained from pain.A revision surgery with proximal femoral locking plates (pflp) was performed to address the issue.The outcome of the patient is unknown.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Du, s.C., wang, x.H., & chang, s.M.(2021).The pre-loaded set-screw in intertan nail: should it be tightened or not tightened in pertrochanteric hip fractures.Geriatric orthopaedic surgery & rehabilitation, 12, 2151459321990640.Doi: 10.1177/2151459321990640.
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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.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.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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Search Alerts/Recalls
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