MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT SOFTWARE TKA VERSION 5; NAVIGATION SYSTEMS AND SUPPORT

Model Number FS235

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.This report is for a similar product.

Event Description

It was reported to aesculap ag that an orthopilot software tka version 5 (part # fs235) was used during a procedure performed on (b)(6) 2022.According to the complainant, when the tibia was cut, an accurate value (varus valgus 0°) was displayed, but when the osteotomy surface was measured with a check plate, it was displayed as valgus 8° and anteversion 4°.The osteotomy surface was confirmed using an alignment rod; the osteotomy was performed at 0°, and it seemed that the navigation display was clearly strange.Surgeon proceeded to four (4) point contact of the femur, and judged that the accurate value was displayed on the femur side; and it did not affect the alignment, so the operation was continued using the orthopilot.The complaint device was not returned to the manufacturer for evaluation.A postoperative x-ray was taken for verification.Additional information was not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.No product available because it is a software.Based on the analysis of the subject expert (see pc 500564570): "the hypothesis of a slight rotation of the tibia transmitter into the tibia bone is plausible according to the results extracted from the log file.An analysis of the full content of the log file has been performed and no other potential cause could have been found." batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 7(10) x probability of occurrence 6(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: ORTHOPILOT SOFTWARE TKA VERSION 5
• Type of Device: NAVIGATION SYSTEMS AND SUPPORT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13517162
• MDR Text Key: 287559123
• Report Number: 9610612-2022-00018
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS235
• Device Catalogue Number: FS235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male