MAUDE Adverse Event Report: AESCULAP AG VEGA PS REMOVABLE TRIAL FEMUR BOX F5; KNEE ENDOPROSTHETICS

Model Number NS825R

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

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 the vega removable trial, femur box.It was noted that the box trial screws threads were stripped (damaged) and would not screw into the implant.This incident did occur in surgery during a vega total knee.There was no patient harm.No additional intervention was required.Additional 'informtaion' has been requested but not yet received as of this report.The malfunction is filed under (b)(4).Involved components (ns825r 500471596).

Manufacturer Narrative

If additional information is received or product is returned, a follow-up will be submitted, if applicable.Manufacturing site evaluation: internal notification number: (b)(4), device reference code ns825r, device name vega ps removable trial femur box f5, serial number n/a, batch number unknown, udi device identifier (b)(4), udi production identifier unknown, basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date unknown.There are no devices available for investigation.No product at hand, therefore a failure description is not possible.Batch history review - the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause - based on the information available it is not possible to determine a definitive root cause for the failure.It could be possible that the failure is usage related.Rationale - in the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.At that time we exclude a design related error because the market feedback is unremarkable on this matter.It could be possible that the corresponding ns428r vega ps fem.Gauge holder/extractor was screwed in the inner thread of the ns825r -> vega ps removable trial femur box f5 in a wrong angle with too much force corrective action - according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

Manufacturer Narrative

General information we received a complaint about one ns825r -> vega ps removable trial femur box f5 from usa.The end customer is unknown.In the meantime the complained device is available for investigation.Consequences for the patient.According to the available information, there were no negative consequences for patient.Investigation: the complained device was examined microscopically with the digital microscope vhx- 5000 keyence eq.-nr.2000024840.The device shows visible traces of usage.It could be determined that the thread of the device is obviously damaged.Batch history review the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause based on the information available as well as a result of our investigation the root cause of the failure is probably usage related.Rationale: there are no hints for a material problem.At that time we exclude a design related error because the market feedback is unremarkable on this matter.It could be possible that the corresponding ns428r vega ps fem.Gauge holder/extractor was screwed in the inner thread of the ns825r -> vega ps.Removable trial femur box f5 in a wrong angle with too much force.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

Event Description

The 8 d report was updated.The product is received for the evaluation.Therefore we create the second follow up.

• Brand Name: VEGA PS REMOVABLE TRIAL FEMUR BOX F5
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9481648
• MDR Text Key: 179422100
• Report Number: 9610612-2019-00796
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS825R
• Device Catalogue Number: NS825R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NS825R(500471596)