MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE INSERT INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10203007
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, during a total ankle arthroplasty, the tip of the cadence insert inserter broke into pieces when the surgeon was using it to implant the polymer insert.All pieces were retrieved.The procedure was resumed, without any delay, using the same device.No patient injury was reported due to this issue.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the peg of the reusable instrument was broken off, the reported event was confirmed.Visual evaluation of the returned device identified the broken off peg as well as signs of wear expected during normal use.The cadence insert inserter is a reusable instrument expected to be used across multiple surgeries.This device is composed of multiple components: a handle, polymer top, and polymer base.Located on the polymer base is a small peg that fits into a small hole located on the anterior of the insert.The complaint indicates that the tip of the cadence insert inserter broke into pieces when the surgeon was using it to implant the polymer insert.Therefore, based upon visual evaluation and the intended use of the device, probable root causes include normal wear and tear and excessive force during insertion.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 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 INSERT INSERTER
• 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: 17347840
• Report Number: 3002788818-2023-00052
• Device Sequence Number: 6068416
• Product Code: LXH
• UDI-Device Identifier: 00885556850954
• UDI-Public: 00885556850954
• 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): 11/08/2023

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: 10203007
• Device Catalogue Number: 10203007
• Device Lot Number: 26291701
• 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: 11/07/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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