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

Catalog Number TFT30101

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

Device report from australia reports an event as follows: it was reported that on (b)(6) 2023 while inserting the last screw in s1, the patient¿s bone did not hold the planned screw as intended (not a good bite).The surgeon had to remove the planned (8x40mm screw) and insert in a (8x45mm) bi-cortically, then made sure that the other s1 (8x40mm) screw was also bi-cortical.Surgeon was then happy with both screw positions.Discarded the 8x40mm screw that was removed.During the case upon inserting the cage the surgeon was inserting the l4/5 cage, the inserter shaft did not engage well, the surgeon removed it from the patient with cage still attached.Upon inspection, the t bar was found to be bent at the tip, and the thread was worn out at the proximal end that engages into the knob.Another inserter from the set was used to insert the cage at l4/5.Then proceeded to insert l5/s1 cage using that second inserter.Once malleted into the disc space and the surgeon was happy with the positioning, he surgeon was unable to remove the inserter from the cage by turning the proximal knob as usual.The inner shaft then broke where the proximal end of the inner shaft is still in the inserter.The distal inner shaft with the t bar at the end came out from the cage.Cage is positioned well in disc space confirmed by x-ray.When the surgeon went to lock off the construct, both x25 final tightening shafts were worn out and just spun inside the head of the screw.Another tray of x25 tighteners were opened and one from that set was used to lock off the construct.The procedure was completed successfully with approximately 2 minutes of delay.There was no reported adverse patient impact.No further information is available.This report is for an implant inserter sh connection.This is report 1 of 4 for (b)(4).

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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.

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: 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 threads of the inner shaft was found stripped, also the tip of the device was found deformed.The observed failures can be attributed to the unable to assemble allegation.No other issues were observed.A dimensional inspection was not performed for the implant inserter sh connection since it was not applicable.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 implant inserter sh connection [tft30101/e19di0971] 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.Device history review (dhr): a review of the receiving inspection (ri) for implant inserter sh connection was conducted identifying that lot number e19di0971 was released in two (2) batches: ¿ batch1: lot qty of (b)(4) units were released on 12-mar-2019 with no discrepancies.¿ batch 2: lot qty of (b)(4) units were released on 04-aug-2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.D10: date of concomitant therapy is (b)(6) 2023.

• Brand Name: IMPLANT INSERTER SH CONNECTION
• 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: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17985838
• MDR Text Key: 326279871
• Report Number: 3013730328-2023-00104
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775592
• UDI-Public: (01)04260557775592
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TFT30101
• Device Lot Number: E19DI0971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• 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: 5.5 EXP VERSE FEN SCR 8.0X40; IMPLANT INSERTER SH CONNECTION; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER
• Patient Sex: Male