MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE TIBIAL IMPACTOR TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10203101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an ankle procedure, the green tip of a cadence tibial impactor tip broke off, making it impossible to attach it to the tibial component.A delay of 2 minutes was reported to occur, and the surgery was resumed with a smith and nephew backup device.No broken pieces entered the patient.The patient was not harmed beyond the reported incident.
Additional Manufacturer Narrative
The product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified no similar reported events for this device nor for the same product lot.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 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.The complaint alleges no injury to the patient, but does allege a brief delay during surgery.It was determined that the device likely contributed to the reported event as the most probable cause of the failure was wear and damage due to normal use.The cadence tibial impactor tip is a reusable instrument expected to be used across multiple surgeries.Further, its intended use is to absorb forces exerted on the tibial tray, an implantable component of the cadence total ankle system, during impaction in order to prevent damage to the implant.Therefore, the plastic tip of the device may fail after prolonged use or if subjected to excessive force, such as during impaction.This probable cause is supported by similar previous complaints.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product 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
H3, h6: this complaint was re-opened as the product has been received at the aus site for evaluation.The complaint was confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified no similar reported events for this device nor for the same product lot.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 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.Visual evaluation: visual evaluation of the cadence tibial impactor tip found that the tip on the reusable instrument was broken off, the reported event was confirmed.The complaint alleges no injury to the patient but does allege a brief delay during surgery.It was determined that the device likely contributed to the reported event as the most probable cause of the failure was wear and damage due to normal use.Visual evaluation of the cadence tibial impactor tip found that the tip on the reusable instrument was missing, the reported event was confirmed.The cadence tibial impactor tip is a reusable instrument expected to be used across multiple surgeries.The cadence tibial impactor tip is composed of multiple components, including a metal base, and a bumper made from radel, a durable plastic.The bumper is not designed to be removed and reattached from the metal base.The complaint alleges that the green tip of the cadence tibial impactor tip was broken off, making it impossible to attach it to the tibial component.This description is consistent with the green radel bumper.The intended use of the device is to absorb forces exerted on the tibial tray, an implantable component of the cadence total ankle system, during impaction in order to prevent damage to the implant.Therefore, the plastic tip of the device may fail after prolonged use or if subjected to excessive force, such as during impaction.The bumper is not designed to be removed and reattached from the metal base.The complaint indicates it was broken off, and based on the design of the device, it is believed that the radel bumper was broken off completely and discarded, and thus not returned with the device for further evaluation.Evaluation of the device suggests that the identified failure mode is consistent with wear and tear damage as a result of normal use of the device.This probable cause is supported by similar previous complaints.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product 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.

• Brand Name: CADENCE TIBIAL IMPACTOR TIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14599421
• Report Number: 3002788818-2022-00030
• Device Sequence Number: 12295054
• Product Code: LXH
• UDI-Device Identifier: 10381780356295
• UDI-Public: 10381780356295
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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: 10203101
• Device Catalogue Number: 10203101
• Device Lot Number: 25052401
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 11/02/2023
• Initial Report FDA Received Date: 06/05/2022
• Supplement Report FDA Received Date: 07/11/2022; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown