MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS FIBULA NAIL, 4.5MM X 180MM, TITANIUM, FLEX-THREAD¿

Model Number	8424-11-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved an intramedullary nail which fractured upon attempted removal.
Additional Manufacturer Narrative
The doctor noted that he did not follow the suggested surgical technique, and attempted to insert the 4.5mm nail after reaming using the 3.2mm reamer, instead of the larger 4.2mm reamer.

• Brand Name: FIBULA NAIL, 4.5MM X 180MM, TITANIUM, FLEX-THREAD¿
• Common Device Name: FIBULA NAIL
• Manufacturer (Section D): CONVENTUS FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• Manufacturer (Section G): ODYSSEY MEDICAL TECHNOLOGIES (CONTRACT MANUFAC.); 2975 brother blvd; barlett TN 38133
• Manufacturer Contact: amanda pentecost ; 100 witmer rd.; ste 280; horsham, PA 19044 ; 2153234029
• MDR Report Key: 13559888
• Report Number: 3009996260-2022-00002
• Device Sequence Number: 4313088
• Product Code: HSB
• UDI-Device Identifier: 00840118116633
• UDI-Public: 00840118116633
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K202858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8424-11-S
• Device Catalogue Number: 8424-11-S
• Device Lot Number: 2107322065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American