MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT CAP SINGLE-USE MARKERS; NAVIGATION SYSTEMS AND SUPPORT

Model Number	FS618SU
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: visual investigation: we made a visual inspection of the products.The products arrived in the original packed and unopened folding boxes.Additionally, the products were sent to the manufacturer for further analysis.Based on the analysis of the manufacturer (see (b)(4)): "however, no deviations were found in these parts.Unfortunately, the cause of the defect for the parts subject to complaint could not be definitively determined." batch history review: the device quality and manufacturing history records (dhr) will be checked for the lot number(s) from the manufacturer of the product.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) 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.Based upon the investigations results a product safety case ((b)(4)) was requested.Any action regarding capa will be addressed with this case.
Event or Problem Description
It was reported that there was an issue with fs618su - orthopilot cap single-use markers.According to the complainant, the navigation with fs100, tkr2, cap marker.No stable visibility of the tibia transmitter.Balls exchanged, no improvement.Navigation aborted, continued with manual surgical technique.An additional medical intervention was necessary.Additional information was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00025 (400508185 - fs618su).
Event or Problem Description
It was reported that there was an issue with fs618su - orthopilot cap single-use markers.According to the complainant, the navigation with fs100, tkr2, cap marker.No stable visibility of the tibia transmitter.Balls exchanged, no improvement.Navigation aborted, continued with manual surgical technique.An additional medical intervention was necessary.Additional information was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00025 (400508185 - fs618su).
Additional Manufacturer Narrative
Investigation results: visual investigation: we made a visual inspection of the products.The products arrived in the original packed and unopened folding boxes.Additionally, the products were sent to the manufacturer for further analysis.Based on the analysis of the manufacturer (see (b)(4)): "however, no deviations were found in these parts.Unfortunately, the cause of the defect for the parts subject to complaint could not be definitively determined." batch history review: the device quality and manufacturing history records (dhr) will be checked for the lot number(s) from the manufacturer of the product.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) 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.Based upon the investigations results a product safety case ((b)(4)) was requested.Any action regarding capa will be addressed with this case.

• Brand Name: ORTHOPILOT CAP SINGLE-USE MARKERS
• Common Device Name: 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: 13515163
• Report Number: 9610612-2022-00017
• Device Sequence Number: 5299264
• Product Code: HAW
• UDI-Device Identifier: 04046964105289
• UDI-Public: 4046964105289
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: FS618SU
• Device Catalogue Number: FS618SU
• Device Lot Number: 19926818D2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown