MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PANTA NAIL. 10MM DIA. X 150MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	PAN-1010-10150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Nonunion/Delayed-union Bone Fracture (2369); Inadequate Osseointegration (2646)
Date of Event	06/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2022, the titanium rod broke.Patient is experiencing chronic pain and need to be operated again.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, as of the date of this medical investigation, clinical documentation has not been received; therefore, it is unknown if the broken rod was a result of delayed/mal/non-union, traumatic injury, mechanical, or other factor(s).The surgical technique does warn that the implants are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.Based on the limited information provided, it cannot be confirmed that the event is related to a mal performance of the component.Reportedly, the broken rod will require additional surgical intervention/revision; however, without patient specific medical documentation, definitive contributing clinical factors could not be concluded.Reportedly, the patient impact related to the broken rod is ¿chronic pain¿ and need for additional surgical intervention.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for panta 2 arthrodesis nail system revealed that fracture of the implant components, pain, discomfort, or abnormal sensations due to presence of the implant are the most frequent adverse events after implanting intramedullary nails.This has been identified as an adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Additionally, part shall comply with the implant and instrumentation manufacturing specification; all implants and instrumentation will be 100% visually inspected.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the fractured intramedullary nail most likely resulted from persistent non-union under the excessive demand of full weight bearing (along with prematurely walking on foot as noted in the ((b)(6) 2023) telemedicine documentation).The provided imaging appears congruent with the radiological reports with intramedullary nail fracture noted approximately 14.5 months post fusion.Additionally, patient age, severe osteoarthritis, and osteopenia coupled with smoking history and nonsteroidal anti-inflammatory drug usage cannot be ruled out as potential contributing factors to the non-union.Patient impact includes the reported joint pain, implant loosening and intramedullary nail fracture in the presence of non-union requiring usage of cam boot and bone stimulator with subsequent joint-fusion revision along with an anticipated transient post-rehabilitative phase.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for panta 2 arthrodesis nail system revealed that fracture of the implant components, pain, discomfort, or abnormal sensations due to presence of the implant are the most frequent adverse events after implanting intramedullary nails.This has been identified as an adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Additionally, part shall comply with the implant and instrumentation manufacturing specification; all implants and instrumentation will be 100% visually inspected.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that, after an internal fixation surgery with a left ankle pcc fusion w/integra im panta nail had been performed on (b)(6) 2022.On (b)(6) 2023, complaints of pain continued, x-ray imaging appears to show the im nail intact but no osseous fusion across the tibiotalar or subtalar joint (non-union) and a ct scan showing small amount of lucency adjacent to the distal portion on the im rod compatible with mild loosening without osseous fusion across the tibiotalar or subtalar joint spaces.On (b)(6) 2023, on a telemed visit, the patient admits to prematurely walking on foot, denies ankle pain at this time but surgeon discussed ct findings and possible need for hw removal/revision and advised to repeat ct scan.On (b)(6) 2023, x-ray ankle imaging report revealed an interval development of a fracture through the im rod at the level of the tibial metaphysis as well as interval development of lucency along the calcaneal screws measuring up to 1 mm.A second surgeon diagnosed painful hw with pseudoarthrosis in the left ttc fusion, a broken im rod, metatarsalgia, ll limb.A new xray showed the crack in the nail¿ for which patient underwent revision on (b)(6) 2024 which included left ankle hw removal, ankle & subtalar joint fusion revision of nonunion, fat pad augmentation, allograft/harvest of tibial autograft, achilles tendon lengthening, and metatarsal osteotomy.Although foot was plantarflexed during the primary ttc fusion, the surgeon recommended ankle should be fused in a neutral position.Current heath status of the patient is unknown.

• Brand Name: PANTA NAIL. 10MM DIA. X 150MM
• 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: 18104464
• Report Number: 3002788818-2023-00096
• Device Sequence Number: 7863126
• Product Code: HSB
• UDI-Device Identifier: 00885556828977
• UDI-Public: 885556828977
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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 Catalogue Number: PAN-1010-10150
• Device Lot Number: UNKNOWN
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 09/20/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/12/2023; 09/20/2024
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female