MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PANTA NAIL. 10MM DIA. X 180MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	PAN-1010-10180
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Implant Pain (4561); Insufficient Information (4580)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after a trauma surgery, fourteen (14) weeks post op, the patient heard a "click".X-rays show fused site, but proximal portion of panta nail.10mm dia.X 180mm, just distal to lower compression slot, is broken.It is unknown how this adverse event was handled.Patient current health status is unknow.
Additional Manufacturer Narrative
A1: patient information updated.B7: other relevant history, including preexisting medical conditions updated.H6: codes updated.
Additional Manufacturer Narrative
H3, h6: the product has not been received at the aus site for evaluation, but photographs were provided.The complaint was confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified no similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is provisionally acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: based on the documentation provided, definitive contributing clinical factors could not be concluded.It is unknown if the early onset of progressive weightbearing (approximately 2 weeks prior to recommendation in the surgical technique) could have contributed to the reported event.The patient impact included the reported click with onset of ankle pain, diagnostic imaging, nail-slot fracture in the presence of ¿fused site¿, and subsequent ¿revision¿/removal of 2 proximal screws with an anticipated transient convalescence phase.Further patient impact cannot be determined.The patient status was reportedly, ¿fair¿.The complaint alleges that revision surgery was required.As the product has not been received for evaluation, it could not be determined whether the device contributed to the reported event.As the product has not been received for evaluation, a definitive root cause could not be determined.The panta nail is a single-use implant made of titanium.The implant is an intramedullary nail used to fixate fractures of the ankle/lower leg.Potential causes for the reported event include incorrect surgical technique, inappropriate patient selection, and premature or excessive loading of the implant.The panta2 instructions for use state that the panta implants ¿are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.Load bearing or weight bearing in the presence of a delayed union or non-union may eventually contribute to or cause implant breakage¿.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.
Additional Manufacturer Narrative
B1, b4: description updated.
Event or Problem Description
It was reported that, after an internal fixation performed on (b)(6) 2022, the patient heard a "click".X-rays show fused site, but proximal portion of panta nail.10mm dia.X 180mm, just distal to lower compression slot, is broken.A revision surgery was performed on (b)(6) 2022, where the two (2) proximal screws were removed.Patient current health status is fair.

• Brand Name: PANTA NAIL. 10MM DIA. X 180MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15956500
• Report Number: 3002788818-2022-00169
• Device Sequence Number: 4938495
• Product Code: HSB
• UDI-Device Identifier: 10381780504313
• UDI-Public: 10381780504313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2023

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 Expiration Date: 03/01/2024
• Device Model Number: PAN-1010-10180
• Device Catalogue Number: PAN-1010-10180
• Device Lot Number: 191655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/09/2023; 01/24/2023
• Initial Report FDA Received Date: 12/11/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/09/2023; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 120 KG