MAUDE Adverse Event Report: AESCULAP AG TRIAL INSERTION INSTRUMENT; INSTRUMENTS INTERBODY FUSION

Model Number	ME020R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with me020r - trial insertion instrument.According to the complaint description, the inserter broke during impaction.This malfunction occurred during a l4-s1 anterior lumbar fusion procedure.The piece was retrieved within ten (10) seconds; there was a three (3) minute delay required to open and load a new cage.Sometimes the disc space is so small, that the trial gets wedged into the disc space.In most cases, a slap hammer is attached to the inserter and used to pull the entire instrument and trial out of the disc space.In this incident, the surgeon hit the underside of the inserter with a mallet.On the underside of the inserter, there is a spring-loaded push button that is used to disassemble the instrument.The surgeon struck the button with the mallet, causing the button to break and the spring to come out.The spring was located.The adverse event is filed under xc reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Investigation results: four instruments "me020r" - hereinafter called "a"; "b"; "c"; and "d" - arrived in decontaminated condition.Product a arrived in damaged condition.Product b also arrived in a damaged condition.Product c arrived in a used condition.Product d also arrived in damaged condition.The insert, button and spring of the instruments arrived separately.First, we made a visual inspection of the instruments.The button, insert and the spring of the instruments a and b are missing.The excerpt of the drawing shows where the button, insert and spring should be.The insert and button on instruments a and b were broken off.The fracture surfaces of the defective parts exhibit the typically signs of a forced fracture.No damage was found on instrument c apart from the usual signs of wear.On instrument d, the weld seam was broken and the axis, which is carrying the rotation star is missing.This means that the rotating star is no longer fixed and therefore fell out.Conclusion root cause analysis description root cause: the root cause for the problem is most probably usage related.The instruments were mechanically overstressed and broke as a result.This is also evident from the wear on the instrument c.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.

• Brand Name: TRIAL INSERTION INSTRUMENT
• Common Device Name: INSTRUMENTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12409868
• Report Number: 2916714-2021-00179
• Device Sequence Number: 3420545
• Product Code: LXH
• UDI-Device Identifier: 04046964093876
• UDI-Public: 4046964093876
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023
• Report Date (Section F): 09/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: ME020R
• Device Catalogue Number: ME020R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 06/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/01/2021