MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH TRIAL, H 11MM, 12°, 32/12; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	TFT31132
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown spinal procedure, the trial implant disengaged from the trial inserter during use.There was a surgical delay of forty-five (45) minutes.The procedure was successfully completed by reattaching the trial implant to the trial implant holder.There was no patient consequence.There is no further information available.This report is for one (1) trial, h 11mm, 12°, 32/12.This is report 1 of 2 for pc-(b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is (b)(6).Without a lot number the device history records review could not be completed.Product was not returned.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.H3, h4, h6: part:tft31132; lot: e19di1438; supplier: (b)(4).Batch1: released on 09 march 2020 with no discrepancies.No nonconformance reports (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 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 h 11mm 12deg 32/12 was returned in an assembled condition.No damage or defects were observed on the surface of the device.A dimensional inspection was unable to be performed due to device design.A functional test was performed to assess the unable to assemble condition.After fully tightening the device, the attached trial was correctly assembled and did not disengaged.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 observed condition of the trial h 11mm 12deg 32/12 would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed.Current and manufactured revisions were reviewed.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: TRIAL, H 11MM, 12°, 32/12
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen 78573 ; GM 78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen 78573 ; GM 78573
• Manufacturer Contact: kasia o'donnell ; eisenbahnstrasse 84; wurmlingen 78573 ; GM 78573 ; 1021462651
• MDR Report Key: 13152068
• Report Number: 3013730328-2022-00003
• Device Sequence Number: 3978560
• Product Code: MAX
• UDI-Device Identifier: 04260557775509
• UDI-Public: (01)04260557775509
• 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 Health Care Professional
• 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: TFT31132
• Device Catalogue Number: TFT31132
• Device Lot Number: E19DI1438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: TRIAL INSERTER SH CONNECTION.
• Patient Sex: Unknown