MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS K-WIRE, 1.6MM X 12", TROCAR/SPADE TIP, FLEX-THREAD¿

Model Number	8531-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event included a conventus flower k-wire that fractured within the medullary canal.X-ray was used to locate and remove the fragment.
Additional Manufacturer Narrative
Patient was described to be young with healthy, strong bone.

• Brand Name: K-WIRE, 1.6MM X 12", TROCAR/SPADE TIP, FLEX-THREAD¿
• Common Device Name: K-WIRE
• Manufacturer (Section D): CONVENTUS FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• Manufacturer (Section G): GSOURCE (CONTRACT MANUFACTURER); 19 bland st; emerson NJ 07630
• Manufacturer Contact: amanda pentecost ; 100 witmer rd.; ste 280; horsham, PA 19044 ; 2153234029
• MDR Report Key: 13441677
• Report Number: 3009996260-2022-00001
• Device Sequence Number: 5363723
• Product Code: HSB
• UDI-Device Identifier: 00840118117487
• UDI-Public: 00840118117487
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8531-1
• Device Catalogue Number: 8531-1
• Device Lot Number: 11109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Hispanic
• Patient Race: White