Uf/importer report # (b)(4) was received at innomed, inc.From the center for devices and radiological health on (b)(4) 2018 with the following event description documented: "tip of carbon fiber hohmann retractor broke during anterior approach total hip surgery.Entire surgery was done under fluoroscopy.No evidence of retained foreign object in patient.Hohman was sequestered and removed from service".Response: an email was sent to the user facility's contact on (b)(4) 2018 requesting to have the device forwarded to innomed for inspection and evaluation.Return merchandise authorization (b)(4) and a sterilization confirmation form was also sent to the contact by innomed on the above referenced date.The device was received at innomed on 11/8/2018.The internal complaints database was surveyed for the described issue associated with 4535-r, modified hohmann retractor-radiolucent.The survey also included review of complaints of retractors similar in design and function: 4550-r, modified blunt hohmann retractor-radiolucent, 4558-r, hohmann retractor 16mm radiolucent, and 7110-r, ortholucent bent hohmann retractor.After receipt at innomed, the device was inspected and evaluated by quality control, and the following inspection results were documented: "performed visual inspection and found evidence of deep cuts across the surface of the working end.The cuts appear to have been made by mechanical means (ref.Attached photos).Cuts to the working end of the instrument create a week point in the plys of the fiberglass/peek material that will result in the instrument breaking.Based on the inspection results there existed no evidence of premature failure or design flaw".No entries documenting the described issue were identified in the database for any of the devices mentioned above.Innomed's capa log was also surveyed for the issue, and no entries were found.
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