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	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, a cadence 45 degree tibial impactor tip is broken.As this was noticed in a non-surgical environment, there was not any patient involved.
Additional Manufacturer Narrative
H3, h6: 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 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 acceptable.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.As the device has not been received for evaluation, a definitive root cause could not be determined.The complaint alleges no injury to the patient nor a 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 due to normal use.The 45-degree 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.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
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Since the product´s breakage occurred outside the surgical environment, the device damage did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly.

• 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: 14727542
• Report Number: 3002788818-2022-00041
• Device Sequence Number: 16707492
• Product Code: LXH
• UDI-Device Identifier: 10381780417132
• UDI-Public: 10381780417132
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 11/07/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/29/2022; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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