MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT BASIS COMPACT; NAVIGATION SYSTEMS AND SUPPORT

Model Number FS101

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

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 orthopilot basis.With the new software (tka 6.0), and this process, the reference point acquisition varies from "simple" to "impossible".The surgeon's concerns included: variation in the degree of difficulty of hip centre acquisition.Uncertainty about the data transmitted.This event/malfunction prolonged the surgery for 25 minutes.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: fs238 orthopilot software tka version 6 batch is unknown.

Manufacturer Narrative

Section d: lot number and serial number clarified.Investigation results: the product was not available for investigation.The information and data forwarded by customer was sent to r&d software solutions department for further investigations.The device history records have been checked for the available lot number(s) and found to be according to the specification, valid at the time of production.There are no similar complaints against the same lot number.Root cause analysis: on the available information it was not possible to identify a final root cause.The problem is likely to be software-design related.The applied software version tka 5.1 shows a lower precision of the algorithm by using a too restrictive threshold than the current software version tka 6.0.Risk analysis: the risk was evaluated based on the applicable product risk analysis.With the result that the severity for a potential harm to patients, users and third parties is defined as "occasionally" (3/5).There is a risk of a potential delay in surgery.However there was no damage to patient, user and third parties reported since the surgeon has still the possibility to continue the surgery with traditional non navigated techniques.Capa: a capa is not necessary since this case is limited to one occurrence.A systematic problem can be excluded because the affected software version tka 5.1 was only produced between november 2019 and june 2020.Today an improved software version tka 6.0 is already available.The affected software version tka 5.1 is not marketed anymore.

• Brand Name: ORTHOPILOT BASIS COMPACT
• Type of Device: NAVIGATION SYSTEMS AND SUPPORT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10123406
• MDR Text Key: 199088428
• Report Number: 9610612-2020-00189
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K080547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS101
• Device Catalogue Number: FS101
• Device Lot Number: 51600199
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FS238 - UNKNOWN