MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH IMPLANT INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	LET30100
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from the united kingdom reports an event as follows: it was reported that on (b)(6)-2023 the patient was undergoing a llif procedure.During insertion of the implant after hammering it into the right position, the knob of the inserter got stuck.The knob wouldn¿t rotate in either direction, making it impossible to detach it from the implant.When the surgeon applied force on the knob, the inner shaft broke.The surgeon decided to keep the implant in the patient, but no further implant inserters were available, so the cage was not optimally placed.The procedure was completed successfully with no adverse patient impact.No further information is available to report.This report is for an implant inserter.This is report 1 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the implant inserter had the proximal end of the inner shaft broken, fragment remains stuck inside between the knob and the outer shaft, making it impossible to disassemble these two components.A functional test was unable to be performed since the damaged current condition of the mating device.A dimensional inspection for the implant inserter was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the trial inserter would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history.Part: let30100.Lot: e20di0221.Supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on nov 30, 2020 with no discrepancies.No ncrs were generated during production.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
H4: manufacture date added.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 corrected data: d10: date of concomitant therapy is (b)(6) 2023.H6: health effect codes updated.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IMPLANT INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; GM D-78573
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18257514
• Report Number: 3013730328-2023-00111
• Device Sequence Number: 6582351
• Product Code: MAX
• UDI-Device Identifier: 04260557837733
• UDI-Public: (01)04260557837733
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LET30100
• Device Lot Number: E20DI0221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 01/09/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/03/2024; 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT INSERTER; TRIAL INSERTER; TRIAL INSERTER; UNK CAGE/SPACER: EIT - LLIF
• Patient Sex: Unknown