MAUDE Adverse Event Report: AESCULAP AG 2-PIN TRANSMITTER FIXATION ELEME; NAVIGATION SYSTEMS AND SUPPORT

Model Number NP1016R

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: no visible deviations could be found.Additionally the products were inspected with the technical product designer of r&d knee arthroplasty and a functional test was made.Based on the functional test, one of the eight products shows no deviation.Furthermore the products were send to the quality assurance of the production department for a destructive testing and further analysis.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 1 similar complaints against the same lot number(s).Conclusion and root cause: due to the circumstance that the products have been sent to the production department for an analysis is this a preliminary report and it will be updated when we received a statement from the production department.The exact cause cannot be determined at this time.Based on the investigations and results of the 8d report no capa is necessary.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 product (b)(4)-pin transmitter fixation element.According to the complaint description, the screws jam intra operative and was unable to tighten/loosen.These have been cross threading and the fixation screw jams, not allowing for the fixation element being able to be tightened or loosened.There are 5 in total and were not able to use, so they opened another set and use the same items from the 2nd set to complete the surgery.The procedure takes about 40min-50mins and the delay was about 5mins.Additional information was not provided nor available / was not available.(b)(4).Associated medwatch-reports: 9610612-2020-00737 ((b)(4)).

Manufacturer Narrative

Additional information: b5 - updated.This is a similar device report; a similar device of the reported device was sold to us, and the reported device is not marketed in the us.Investigation: we made a visual inspection of the products.The products belong to 3 linked complaints.No visible deviations could be found.Additionally the product were inspected with the technical product designer of r&d knee arthroplasy and a functional test was made.Based on the functional test, one of the eight products showed no deviation.Furthermore, the products were sent to the quality assurance section of the production department.The subject matter expert also provided feedback.There is possibility of a production-related cause.An auxiliary device is now used so that only the screw head and not the thread is under load during wobbling.In addition, an assembly check with a 100% test of the ease of movement and freedom from clamping of the screw has been added.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There is one similar complaint against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level ((3)5 severity x (1)5 probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably manufacturing-related.According to the investigation results, changes have already been implemented in production.

Event Description

Update: the pins were used over a 2-3 week period in approximately 10 cases before failure.The procedures were all navigated total knee replacements.The adverse event/malfunction is filed under aag reference (b)(4).Associated medwatch reports: 400483278 (9610612-2020-00003), 400483279 (9610612-2020-00736), 400477035 (9610612-2020-00750).

• Brand Name: 2-PIN TRANSMITTER FIXATION ELEME
• Type of Device: 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: 10788780
• MDR Text Key: 223164571
• Report Number: 9610612-2020-00736
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NP1016R
• Device Catalogue Number: NP1016R
• Device Lot Number: 52596903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1