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

Model Number FS618SU

Device Problems Misconnection (1399); Product Quality Problem (1506)

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

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event 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).

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
• Type of Device: NAVIGATION SYSTEMS AND SUPPORT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11496723
• MDR Text Key: 253234421
• Report Number: 9610612-2021-00177
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04046964105289
• UDI-Public: 4046964105289
• Combination Product (y/n): N
• PMA/PMN Number: K013569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS618SU
• Device Catalogue Number: FS618SU
• Device Lot Number: 19916318D2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1