MAUDE Adverse Event Report: FLOWER ORTHOPEDICS CANNULATED SCREW, PARTIALLY THREADED D: 4.0MM X L:40MM; PARTIALLY THREADED CANNULATED SCREW

Model Number	CNP 440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon described inserting and backing out the screw cyclically to "tap" the screw threads due to high bone density.
Event or Problem Description
The event included the shearing of the tip of a partially threaded cannulated screw during implantation.The affected hardware was left in the patient.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED D: 4.0MM X L:40MM
• Common Device Name: PARTIALLY THREADED CANNULATED SCREW
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• MDR Report Key: 12191392
• Report Number: 3009996260-2021-00010
• Device Sequence Number: 17207253
• Product Code: HWC
• UDI-Device Identifier: 00840118110723
• UDI-Public: 00840118110723
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: CNP 440
• Device Catalogue Number: CNP 440
• Device Lot Number: 2103321449
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 64