MAUDE Adverse Event Report: ORTHOPAEDIC IMPLANT COMPANY, THE OIC INTRAMEDULLARY NAIL SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GW03-1000-S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The or technician was preparing instruments for a case.During a pre-run of one of the devices to make sure it would work properly before starting the case, a guide rod got stuck in an oic handle.After many attempts by the or tech and surgeon, it was determined that the guide rod was malfunctioning.A new guide rod and oic im nail base set were opened and everything went fine afterward.Device information: guide rod is oic 3.0mm x 1000mm ball tip guide rod.Sterile part # gw03-1000-s.Lot # 19-02005.The handle came from the oic im nail base set (yellow t-shaped handle).

• Brand Name: OIC INTRAMEDULLARY NAIL SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ORTHOPAEDIC IMPLANT COMPANY, THE; 770 smithridge dr; ste 400; reno NV 89502
• MDR Report Key: 10710994
• Report Number: 10710994
• Device Sequence Number: 3482844
• Product Code: HSB
• UDI-Device Identifier: 10811998036851
• UDI-Public: (01)10811998036851
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2020
• Report Date (Section F): 10/08/2020

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: Other
• Device Model Number: GW03-1000-S
• Device Lot Number: 19-02005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/08/2020