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

Model Number	FS618SU
Medical Device Problem Codes	Misconnection (1399); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with fs618su - orthopilot cap single-use markers.According to the complaint description, the users reported during the procedure, the orthopilot no longer recognised the marker.The marker stopped working due to the lack of a reflective area.As a result of this defect,the team had to change the detector, causing a slight delay in the procedure.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Additional 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.Batch history review: review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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 CAP SINGLE-USE MARKERS
• Common Device Name: NAVIGATION SYSTEMS AND SUPPORT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11496723
• Report Number: 9610612-2021-00177
• Device Sequence Number: 2856657
• Product Code: HAW
• UDI-Device Identifier: 04046964105289
• UDI-Public: 4046964105289
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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 Expiration Date: 06/30/2024
• Device Model Number: FS618SU
• Device Catalogue Number: FS618SU
• Device Lot Number: 19916318D2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1