MAUDE Adverse Event Report: INNOMED, INC. MODIFIED HOHMANN RETRACTOR RADIOLUCENT; ORTHOPEDIC RETRACTOR

Model Number	4535-R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
[(b)(4)].
Event or Problem Description
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.

• Brand Name: MODIFIED HOHMANN RETRACTOR RADIOLUCENT
• Common Device Name: ORTHOPEDIC RETRACTOR
• Manufacturer (Section D): INNOMED, INC.; 130 estus drive; savannah GA 31404
• MDR Report Key: 8086985
• Report Number: 1833053-2018-00002
• Device Sequence Number: 1579326
• Product Code: GAD
• UDI-Device Identifier: 00840277108098
• UDI-Public: 00840277108098
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/19/2018
• Report Date (Section F): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4535-R
• Device Catalogue Number: 4535-R
• Device Lot Number: 1216GSL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 10/03/2018