MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE IMPLANT PROTECTOR - RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10204305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total ankle system surgery, the holder on the right side of the cadence implant protector - right broke off while trying to place it in the tibial implant.Flouro and visualization confirmed that all parts were retrieved and accounted for.No delay or further complications were reported as a consequence of this problem.It is unknown how the procedure was resumed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The product has not been received at the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.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): 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.Dhr/batch record review: as the product lot number was not reported, the dhr/batch record review could not be completed.Visual inspection: visual inspection was unable to be performed because the device has not been received for evaluation.The complaint alleges no injury to the patient nor a delay during surgery.As the product has not been received for evaluation, it could not be determined whether the device contributed to the reported event.As the product lot number was not reported, a determination of whether the device met manufacturing specifications could not be made.The cadence implant protector is a reusable instrument expected to be used across multiple surgeries.The instrument is made of plastic and is used to protect the implant from direct forces during impaction for implantation.Potential causes for the reported event include wear due to normal use or exposure to excessive impaction forces.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing 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 associated device was returned and evaluated.The visual inspection revealed that the reusable instrument was broken.Visual evaluation identified signs of wear due to normal use and damage along the edge of the device.Based on visual evaluation and nature of the device, some potential causes for the reported event include wear due to normal use or exposure to excessive impaction forces.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 IMPLANT PROTECTOR - RIGHT
• 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: 16989227
• Report Number: 3002788818-2023-00041
• Device Sequence Number: 17875452
• Product Code: LXH
• UDI-Device Identifier: 00885556851760
• UDI-Public: 00885556851760
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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: 10204305
• Device Catalogue Number: 10204305
• Device Lot Number: UNKNOWN
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 11/23/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/13/2023; 11/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown