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

Model Number PET30101

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

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: patient identifier: (b)(6).Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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.

Event Description

It was reported that on december 7, 2022, during implantation of a conduit straight t/pluf cage, the inner driver of the implant holder was found to be disconnected from its handle.This locked the implant to the driver, and prevented the implant from being detached after implantation.The surgeon had to explant and waste the cage.Another cage of the same size was opened, and a different implant inserter was used to complete the surgery.There was a surgical delay of 2 minutes.The implant and implant holder were removed, and a new implant was opened and inserted.The procedure was successfully completed and there was no patient consequence.No further information is available.This report involves one t-handle inserter.This is report 1 of 2 for (b)(4).

• Brand Name: T-HANDLE INSERTER
• Type of Device: 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: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 16077430
• MDR Text Key: 307176643
• Report Number: 3013730328-2022-00102
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PET30101
• Device Catalogue Number: PET30101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INSERTER SH CONNECTION; POST IBF UI H 10MM 8DEG 26/9
• Patient Age: 75 YR
• Patient Sex: Female