MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE 45 DEGREE TIBIAL IMPACTOR TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10203102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, one (1) cadence 45 degree tibial impactor tip broke when surgeon was using it to implant tibial component in patient.All pieces were retrieved.The procedure was resumed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that the tip on the reusable instrument was broken off, the reported event was confirmed.Visual evaluation of the device identified a broken off piece of the plastic tip and additional fracture.More signs of wear were identified along the body of the reusable instrument.The cadence 45 degree 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 implantable components 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.Evaluation 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.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.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.

• Brand Name: CADENCE 45 DEGREE 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: 17347839
• Report Number: 3002788818-2023-00053
• Device Sequence Number: 6068415
• Product Code: LXH
• UDI-Device Identifier: 00885556851081
• UDI-Public: 00885556851081
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 10203102
• Device Catalogue Number: 10203102
• Device Lot Number: 278484-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Patient Sex: Unknown