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U.S. Department of Health and Human Services

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

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ORTHOPAEDIC IMPLANT COMPANY, THE OIC INTRAMEDULLARY NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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).
 
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Brand NameOIC INTRAMEDULLARY NAIL SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ORTHOPAEDIC IMPLANT COMPANY, THE
770 smithridge dr
ste 400
reno NV 89502
MDR Report Key10710994
MDR Text Key212332181
Report Number10710994
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberGW03-1000-S
Device Lot Number19-02005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/08/2020
Event Location Hospital
Date Report to Manufacturer10/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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