SMITH & NEPHEW, INC. UNKN SUSPENSORY FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 02/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Literature: a novel double-endobutton device assisted shoulder arthroscopy in treating neer type lib distal clavicle fracture.
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Event Description
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It was reported that on literature review, "a novel double-endobutton device assisted shoulder arthroscopy in treating neer type lib distal clavicle fracture", a case of non-union was reported after surgery with an endobutton.The patient was re-operated, underwent 3 times of intraoperative bone grafting and postoperative prp treatment, the patient¿s fracture healed three months after operation.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was an isolated event.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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