MAUDE Adverse Event Report: FLOWER ORTHOPEDICS FLOWER ORTHOPEDICS CANNULATED SCREWDRIVER (T25)

Model Number	GWK 300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The event included a fractured flower screwdriver.X-ray was used to locate and remove all fragments.

• Brand Name: FLOWER ORTHOPEDICS CANNULATED SCREWDRIVER (T25)
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• MDR Report Key: 11776817
• Report Number: 3009996260-2021-00006
• Device Sequence Number: 14322970
• Product Code: HXX
• UDI-Device Identifier: 00840118110853
• UDI-Public: 00840118110853
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: GWK 300
• Device Catalogue Number: CSD 025
• Device Lot Number: 1902390123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3009996260-41521-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91