MAUDE Adverse Event Report: SONOMA ORTHOPEDIC PRODUCTS SONOMA FIBULOCK NAIL RIGHT 3.0X130MM; ROD FIXATION, INTRAMEDULLARY

Catalog Number FIB30130R

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/01/2017

Event Type  malfunction  

Event Description

Pt with a right trimalleolar ankle fracture underwent open reduction internal fixation under fluoroscopic guidance.After the reaming, the nail was wedged due to a bend in the "interrocous" canal.With removal, the tip of the nail came off and remained in the canal.

• Brand Name: SONOMA FIBULOCK NAIL RIGHT 3.0X130MM
• Type of Device: ROD FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SONOMA ORTHOPEDIC PRODUCTS; buffalo grove IL
• MDR Report Key: 6857597
• MDR Text Key: 85995339
• Report Number: MW5072092
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2017

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: Health Professional
• Device Catalogue Number: FIB30130R
• Device Lot Number: CUO71116-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 55