MAUDE Adverse Event Report: ORTHOFIX US LLC FIREBIRD SFS; ROD GRIPPER

Model Number	51-1480
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has returned for investigation but the investigation is not complete.A supplemental report will be complected once the investigation is done.
Event or Problem Description
It was reported that during a scoliosis surgery, the screw of the gripper moved out of place.Surgery was completed with another rod gripper that was inside of the tray with no adverse effects to the patient.Reporting for a one hour time delay in surgery.
Additional Manufacturer Narrative
The rod gripper (pn:51-1480 ln:39802-pe09) was returned for investigation and sent to the mor for evaluation.Fa from gauthier: the pin (screw) set closest to the jaws.That came off in the field, was not returned with the part.When a new set of pins was used to replace the missing pair, the rod gripper was tested and would function properly.The 3 sets of pins on the part were checked for adhesive strength.The 1st set closest to the teeth would readily unthread with slight effort.The 2nd set of pins would easily unthread when checked.The 3rd set of pins was still securely held together with adhesive.With some significant effort, these were also able to be unthreaded.The threads were checked on all 3 sets and the 1st and 2nd set closest to the teeth had dried but adequate adhesive observed on the threads, and the 3rd set still had dried but significant adhesive on the threads.As the pin set that came loose was not returned.The threads on those pins were not able to be checked for adequate adhesive.The adhesive on the 3 checked sets had worn out most likely due to significant sterilization/drying cycles over the 11 years of part usage.The teeth on the gripper were also checked and found to be worn on their side edges, where some material was found to be rolled over the ends, from usage.Some wear on the components was observed between the moving parts of the rod gripper.The laser marking on the part was observed to be worn from usage over time.The rod gripper has most likely seen significant use i number of sterilizations as the part is over 11 years old.The root cause of the pin set that unthreaded and came off the rod gripper was most likely due to the number of sterilization/drying cycles causing the adhesive to wear out over the years of service, allowing for the pins to unthread and come off the instrument.The dhr was reviewed for this order and there were no nonconformance found that would have contributed to this complaint.The wo (b)(4) part for this complaint was returned to gauthier on 12-19-2024.The pin( screw) set closest to the jaws.That came off in the field, was not returned with the part.This part originally shipped from gauthier in may 2013, and has most likely been in the field for over 11 years.The instrument had minimal wear marks from usage over the years.The p/n # 51 -1480 and lot # 39802-pe09 were laser marked on the part and were worn from usage.
Event or Problem Description
It was reported that during a scoliosis surgery, the screw of the gripper moved out of place.Surgery was completed with another rod gripper that was inside of the tray with no adverse effects to the patient.Reporting for a one hour time delay in surgery.

• Brand Name: FIREBIRD SFS
• Common Device Name: ROD GRIPPER
• Manufacturer (Section D): ORTHOFIX US LLC; 3451 plano parkway; lewsiville TX 75056
• Manufacturer (Section G): ORTHOFIX US LLC; 3451 plano parkway; lewsiville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano parkway; lewisville, TX 75056
• MDR Report Key: 20955466
• Report Number: 2183449-2024-00026
• Device Sequence Number: 12873719
• Product Code: LXH
• UDI-Device Identifier: 18257200045600
• UDI-Public: 18257200045600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 51-1480
• Device Lot Number: 39802-PE09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown