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

Model Number TFT30101

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

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-2012 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on 08-apr-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.Visual inspection: the implant insertion sh connection (p/n: tft30101, lot #: e19di0971) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the implant inserter knob sh connection component was missing from the device.The threads of the implant inserter pin sh connection component (tft30101 b) were observed to be stripped.The distal tabs of the implant inserter sh connection component (tft30101 a) were slightly deformed and there were scratches on the device but have no impact on the complaint condition.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review the following drawing was reviewed.Tft30101 implant inserter sh connection.Complaint confirmed? yes, the device received was deformed.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the implant insertion sh connection (p/n: tft30101, lot #: e19di0971).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 while the cage was impacted, on the ap image the cage had pivoted autonomously, without winding the inserter clockwise.When the slap hammer was used to remove the cage and reinsert it the same thing happened.On the third attempt, the cage was reloaded and the position seemed more solid.Upon inspection the threads on the inner shaft of the cage inserter were worn.The surgery was completed successfully with a ten (10) minute delay.Concomitant device: unknown hammer (part# unknown, lot# unknown, quantity unknown).This report is for one (1) implant inserter sh connection.This is report 1 of 1 for (b)(4).

• 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; DE D-78573
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 10648729
• MDR Text Key: 210406402
• Report Number: 3013730328-2020-00025
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775592
• UDI-Public: 04260557775592
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2020

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
• Device Operator: Health Professional
• Device Model Number: TFT30101
• Device Catalogue Number: TFT30101
• Device Lot Number: E19DI0971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2012
• 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: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE