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

Model Number	TFT20101
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
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.Without a lot number the device history records review could not be completed.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in switzerland as follows: it was reported that on (b)(6) 2022, the conduit tlif trial implant holder was difficult to disassemble following surgery.There were no reported patient consequences or delays in surgery.This report involves one (1) trial inserter sh connection this is report 1 of 1 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.Part# tft20101; lot # e19di1432; supplier:(b)(4).Batch1: lot qty of (b)(4) units were released on 23 dec 2021 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 27 jul 2021 with no discrepancies.Batch3: lot qty of (b)(4) units were released on 01 jun 2021 with no discrepancies.Batch4: lot qty of (b)(4) units were released on 10 mar 2021 with no discrepancies.Batch5: lot qty of (b)(4) units were released on 05 jan 2021 with no discrepancies.Batch6: lot qty of (b)(4) units were released on 05 jan 2021 with no discrepancies.Batch7: lot qty of (b)(4) units were released on 05 jan 2021 with no discrepancies.Batch8: lot qty of (b)(4) units were released on 07 dec 2020 with no discrepancies.Batch9: lot qty of (b)(4) units were released on 03 dec 2020 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo did not identify anything indicative of a product defect with trial inserter sh connection.Product functionality can not be assessed through a photo investigation.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 trial inserter sh connection was returned in a disassembled condition.There was no damage or defects observed on the surface of the device.A dimensional inspection was performed for the trial inserter sh connection and met specifications.A functional test to assemble the trial inserter pin sh connection to the tft20101 trial inserter sh connection was conducted and the devices were assembled successfully.No problems were detected after successfully attempting to disassemble the devices.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the trial inserter sh connection was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.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: EIT TLIF 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
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen, MA D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 14083818
• Report Number: 3013730328-2022-00032
• Device Sequence Number: 5251700
• Product Code: MAX
• UDI-Device Identifier: 04260557775578
• UDI-Public: 04260557775578
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Model Number: TFT20101
• Device Catalogue Number: TFT20101
• Device Lot Number: E19DI1432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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
• Patient Sex: Unknown