MAUDE Adverse Event Report: AESCULAP AG VEGA PS INSERTION INSTR.F/TRIAL FEMUR; KNEE ENDOPROSTHETICS

Model Number NS371R

Device Problem Mechanical Problem (1384)

Patient Problem Joint Disorder (2373)

Event Date 11/20/2019

Event Type  Injury  

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 product vega insertion instrument.The insertion instrument would not be firmly connected to a trial femoral insert.As a result, the trial insert accidentally disconnected itself from the instrument and fell on the floor.Staff resterilized the contaminated trial insert and the surgeon attempted again to connect the insert and the instrument.However, these attempts were not successful.Finally, the surgeon manually inserted the trial insert.There was a surgical delay of 40 minutes.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

General information: we received a complaint about one (b)(6) -> vega ps insertion instr.F/trial femur from the (b)(6) memorial, (b)(6), japan.The complained device is available for investigation in a decontaminated condition consequences for the patient surgery delay longer than 15 minutes.Investigation the complained device shows visible traces of usage.The components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The complained device was sent to the responsible manufacturing department for investigation.Response from the manufacturing department: working end/main part of the instrument can be screwed clear onto the rod (testing equipment ident-nr.31889).On production side no failure could be determined.The complained product was manufactured in 2015 and shows visible traces of usages at the working end/main part of the instrument.Furthermore this case was discussed with a specialist from the product management.In a test a (b)(6) -> vega ps trial femoral component f5n l was connected with the complained device.Result: strong connection of the two devices -> no connection failure could be found.Unfortunately we did not receive the respective trial femoral insert for investigation.Therefore the investigation remains incomplete.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 respective trail femoral insert for investigation, it is not possible to determine a definitive root cause for the mentioned failure.There are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.At that time we exclude a design related error because the market feedback is unremarkable on this matter.On production side no failure could be determined.Result of the test: strong connection of the two devices -> no connection failure could be found.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: VEGA PS INSERTION INSTR.F/TRIAL FEMUR
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9433296
• MDR Text Key: 170082973
• Report Number: 9610612-2019-00824
• Device Sequence Number: 1
• Product Code: LXH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS371R
• Device Catalogue Number: NS371R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention