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

Model Number	TFT20101
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2021, the product was found to be defective.This report is for one (1) implant inserter sh connection.This is report 2 of 2 for complaint (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.Additional narrative: a device history record (dhr) review was conducted: visual inspection: the complaint device trial inserter sh connection was returned to cq west chester for investigation along with implant inserter pin and knob.The trial shaft had the implant inserter knob(tft:30101b) locked on to its end and the opening of the shaft for the pin appeared deformed.Functional test: the implant inserter knob could not be removed from the trial shaft as a broken piece of inserter pin was jammed inside the shaft & knob.Can the complaint be replicated - yes, the complaint condition can be replicated.Document /specification review: based on the date of manufacture, current and manufactured revision of drawings were reviewed.Dimensional inspection: complaint relevant dimension cannot be measured without the destruction of the device.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the implant inserter pin and knob were used with trial inserter shaft.The implant inserter might have been incompatible with the trial shaft leading to the complaint issue.This is could be a user error.But a definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot - part # tft20101 synthes lot # e19di1432 supplier lot # e19di1432 release to warehouse date: 02 jun 2020 supplier: (b)(4) no ncr's 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.

• Brand Name: TRIAL INSERTER SH CONNECTION
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; DE D-78573
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13568935
• Report Number: 3013730328-2022-00014
• Device Sequence Number: 6062148
• Product Code: MAX
• UDI-Device Identifier: 04260557775578
• UDI-Public: (01)04260557775578
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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

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: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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 SH CONNECTION
• Patient Sex: Unknown