MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE SIZE 1 INSERT TRIAL. 6MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	10206106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a cadence size 1 insert trial.6mm broke in total ankle system case today.It is unknown the exact moment when the event happened and how the procedure was resumed.No patient injuries or other complications were reported.No further information is available.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.Evaluation of the returned device found that the tabs/slot of the trial were damaged.A portion of the tab was broken off and missing.This aligns with the reported failure.In addition, there were deep gouges near the opening and denting along the edges of the device.Evaluation of the returned device indicates that the most probable cause for the breakage is wear due to normal use.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 evidence to conclude 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 SIZE 1 INSERT TRIAL. 6MM
• 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: 19929657
• Report Number: 3002788818-2024-00090
• Device Sequence Number: 11447151
• Product Code: LXH
• UDI-Device Identifier: 00885556851937
• UDI-Public: 00885556851937
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/28/2024

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 Catalogue Number: 10206106
• Device Lot Number: QJ1292
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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