MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION DEVICE

Model Number	FHTPCS0026TT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the devices were not returned for analysis, a definitive cause for this failure could not be determined.Based on the event description, it is possible that the insertion instrument was over-torqued which resulted in the core of the shell breaking.It is also possible that the guide pin was not threaded correctly onto the shell during implant loading.However, without return of the implant this cannot be confirmed.However, based on the investigation results there is no evidence to suggest manufacturing issues caused the failure.There were no failure related complaints or ncmrs on either the shell or the guide pin lots.However, for the shell that was left implanted and packed with bone graft without a shim, the event can be attributed to unintended user error as stm-00019 flarehawk7 and tihawk7 mis surgical technique manual and stm-00008 flarehawk 7 and tihawk7 open surgical technique manual both caution against this.It's noted in both stms that "an unlocked implant or implant without a shim should never be left in a patient." and "removal of the shim from the implant assembly for any reason requires removal of the shell and replacement with a new shell.".Although no patient harms were reported, a complaint where a shell without any shim was left in place has caused or contributed to a serious injury.Therefore, it was determined that this complaint does meet the definition of reportable event and this complaint was updated with the mdr submission.No further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.
Event or Problem Description
On 08apr2022, accellus was made aware of a complaint regarding a guide pin which, during a procedure, would not adhere to the shim and shell.After multiple attempts to reattach a new guide pin through the shim and onto the core of the shell, it was determined that the best course of action was to remove the implant prior to reaching full expansion.Shim removal tool was used to remove shim, shell removal tool was used to reverse shell back a few millimeters, then shell was placed in midline position and packed with bone graft, then pedicle screws were placed.There was no harm to the patient reported as a result of this occurrence.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: FLAREHAWK INTERBODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: chris mckee ; 354 hiatt drive; palm beach gardens, FL 33418 ; 9014939467
• MDR Report Key: 21144127
• Report Number: 3012797630-2025-00002
• Device Sequence Number: 9262655
• Product Code: MAX
• UDI-Device Identifier: 00810045530185
• UDI-Public: (01)00810045530185(10)11210138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: FHTPCS0026TT
• Device Catalogue Number: FHTPCS0026TT
• Device Lot Number: 11210138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White