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: the products arrived in a decontaminated status with visible damaged glass ball coating.We made a visual inspection of the products.Ten products have a visible damaged glass ball coating.Additionally the products were sent to the manufacturer for further analysis.Based on the analysis report of the manufacturer (see pc (b)(4)): "examination of the operation plans of batches 20910718d3 and 20911318d3 and the retain sample 20911518d3.No discrepancies present in the manufacturing documentation.Parts reclaimed on 2021-06-01 (16 pieces 20910718d3 and 8 pieces 20911318d3 received by atesos) and transferred to qa for further clarification: no measurable findings, as reclaimed parts were delivered decontaminated from the clinics.Visually, no obvious damage was apparent.Cause unclear, since all parts are subjected to a 100% optical inspection before delivery." batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that 1 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 initiated.Any action regarding capa will be addressed with this case.
Event or Problem Description
It was reported to aesculap ag that an orthopilot cap single-use markers (part # fs618su) was used during a procedure performed on an unknown.According to the complainant, there was no stable visibility of transmitter.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

• 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: 12975851
• Report Number: 9610612-2021-00762
• Device Sequence Number: 4278113
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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: 04/30/2025
• Device Model Number: FS618SU
• Device Catalogue Number: FS618SU
• Device Lot Number: 20910718D3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2020
• 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