MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC FIREBIRD SFS; PEDICAL SCREW, MODULAR

Catalog Number	44-5545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that the patient had spine fixation surgery in (b)(6) 2023.X-ray images taken in (b)(6) show a broken bone screw.A revision surgery was performed to remove/replace the broken screw.
Additional Manufacturer Narrative
The device was received and is currently pending evaluation.
Event or Problem Description
The device was returned for investigation.No ncmrs were associated with this lot or failure reported.Without the ln of the screw, a review of the dhr and ncmr database could not be completed.The 5.5x45mm modular bone screw and top loading body (pn: 44-5545 and 36-2101, ln: unk and o65) were returned for investigation.Information provided stated that there was an incident involving a firebird screw from a surgery done in february.Inspection of the returned product confirmed the screw was broken and the head of the screw was jammed in the top loading body.Numerous attempts were made to gather necessary additional information without success.Without additional radiographic images, it was not possible to assess the potential role of surgical technique or patient selection.Based on the limited information provided, it was not possible to determine the cause of this reported failure.This is the 1st occurrence of this reported failure mode for pn: 44-5545 in the past 2 years out of approximately (b)(4) units sold.The estimated occurrence rate is (b)(4), which corresponds to a level 2 (remote).This is the 1st occurrence of this reported failure mode for pn: 36-2101 in the past 2 years out of approximately (b)(4) units sold.The estimated occurrence rate is (b)(4), which corresponds to a level 1 (improbable).

• Brand Name: FIREBIRD SFS
• Common Device Name: PEDICAL SCREW, MODULAR
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 18257350
• Report Number: 2183449-2023-00006
• Device Sequence Number: 7060033
• Product Code: NKB
• UDI-Device Identifier: 18257200113545
• UDI-Public: 18257200113545
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 04/01/2024

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: Lay User/Patient
• Device Catalogue Number: 44-5545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female