MAUDE Adverse Event Report: AESCULAP AG IQ IMPLANT HOLDING/INSERTION INSTRUMENT; KNEE ENDOPROSTHETICS

Model Number NS600R

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

General information: we received a complaint about one ns600r -> iq implant holding/insertion instrument from the orthopädische universitätsklinik, frankfurt am main, germany.The available devices were decontaminated internally according to internal standards.Involved component: ref.Code device name batch: nn004z as columbus cr femoral comp.Cemented f4l 52545957 nq1031 iq columbus insert femur small f/ns600r unknown the following information was provided: instrument could not be detached from implant.The cemented implant had to be replaced with a narrow version.Consequences for the patient: surgery delay longer than 15 minutes.Investigation: it is not possible to loose the femoral component from the implant holding instrument.The components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".We received the holding instrument and the implant component in a condition which did not allow to loose the connection between both devices.Both devices (in the connected condition) were presented to the product management.As a next step a few drops of oil were dribbled into the gap between the expander and the thread of the handle.Result: after a few tries it was possible to loose the thread connection between the handle and the expander.The thread of the handle shows visible scoring damages.Batch history review the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.One more similar incidents has been found with products from the batch 52279035.The root cause for this failure was insufficient oiling.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient maintenance of the device.Rationale: 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.The outer thread of the handle shows visible scoring damages which we attribute to an insufficient oiling.Due to the construction of the device (metal surfaces moving against each other) a regular/constant oiling is essential.Without appropriate lubricants, increased friction, and scoring damages are unavoidable.In our experience, machine care additives only have a slight lubricating effects , so that we can only point out to use special instrument care oils (for example aesculap sterilit) to avoid such damage.This is also mentioned in the instructions for use (ifu).Corrective action: according to sop (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

It was reported that there was an issue with iq implant holding/insertion instrument.(leading material) according to the customer report: "instrument could not be detached from implant.The cemented implant had to be replaced with a narrow version." this event prolonged the surgery for 15 minutes.Additional medical intervention was necessary.As a replacement a columbus narrow gr.4 was implanted.The adverse event is filed under (b)(4).Associated medwatch reports: 9610612-2019-00964 ((b)(4) nn004z) see involved components involved components: nq1031 - iq columbus insert femur small f/ns600r - unknown.Nn004z - as columbus cr femoral comp.Cemented f4l - 52545957.

• Brand Name: IQ IMPLANT HOLDING/INSERTION INSTRUMENT
• Type of Device: KNEE ENDOPROSTHETICS
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9753316
• MDR Text Key: 181644216
• Report Number: 9610612-2019-00963
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2020

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
• Device Operator: Health Professional
• Device Model Number: NS600R
• Device Catalogue Number: NS600R
• Device Lot Number: 52279035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention