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

Model Number GW03-1000-S

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2020

Event Type  malfunction  

Event 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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ORTHOPAEDIC IMPLANT COMPANY, THE; 770 smithridge dr; ste 400; reno NV 89502
• MDR Report Key: 10710994
• MDR Text Key: 212332181
• Report Number: 10710994
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10811998036851
• UDI-Public: (01)10811998036851
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: GW03-1000-S
• Device Lot Number: 19-02005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1