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

Model Number	CNP 432
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The event included a screw which collided with implanted screw during insertion and fractured upon impact.

• Brand Name: FLOWER ORTHOPEDICS CORPORATION
• Common Device Name: CANNULATED SCREW, PARTIALLY THREADED, D: 4.0MM
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd., ste 280; horsham PA 19044
• MDR Report Key: 11509368
• Report Number: 3009996260-2021-00003
• Device Sequence Number: 17043848
• Product Code: HWC
• UDI-Device Identifier: 00840118110686
• UDI-Public: 00840118110686
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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 Expiration Date: 04/01/2022
• Device Model Number: CNP 432
• Device Catalogue Number: CNP 432
• Device Lot Number: 2015001033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 93