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

Model Number TFT30101

Device Problem Break (1069)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A product investigation was conducted.Visual inspection: the implant inserter sh connection (p/n: tft30101, lot #: e17di0500) was returned and received at us cq.Upon visual inspection, it was observed that the entire threaded portion of the tft30101 c tlif implant inserter pin sh connection was broken and the broken fragment was lodged inside the implant inserter (p/n: tft30101 a) and the knob (p/n: tft30101 b).There were scratches on the device but has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed investigation conclusion: the complaint condition is confirmed for the implant inserter sh connection pin (p/n: tft30101, lot #: e17di0500).There is no indication that a design or manufacturing issue has caused the issue 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.A device history record (dhr) review was conducted: part number: tft30101, lot number: e17di0500.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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 synthes reports an event in (b)(6) as follows: it was reported that during spinal fixation surgery on (b)(6) 2019, the inserter was used to insert the conduit tlif implant.Upon tapping the inserter with a hammer, according to the surgical technique, the implant started to turn too soon.The fixation knob was tightened as much as possible, yet still the implant started to hinge on the holder (as it was designed to do, but only after loosening of the fixation knob, which was not yet done in this case).There might have been tissue damage caused, but this was not confirmed as no report was made to the dps/jnj rep.A tamp was used to insert the implant to its correct position.The insertion instrument was handed over to dps/jnj rep with a broken inner shaft, yet no report was made to us this breakage occurred intraoperatively.The inner shaft of the inserter broke at the designed point high inside the outer shaft.No further information was provided.During manufacturer's preliminary investigation of the returned device on january 17, 2020 it was identified that the entire threaded portion of the tft30101 c tlif implant inserter pin sh connection was broken and the broken fragment was lodged inside the implant inserter.Concomitant device: implant inserter sh connection (product code: tft30101, lot #: e18di0449 qty: 1).This report is for one (1) implant inserter sh connection.This is report 9 of 9 for complaint (b)(4).

• Brand Name: IMPLANT INSERTER SH CONNECTION
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; GM D-78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; GM D-78573
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9603825
• MDR Text Key: 188836743
• Report Number: 3013730328-2020-00008
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775592
• UDI-Public: (01)04260557775592
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172888
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFT30101
• Device Catalogue Number: TFT30101
• Device Lot Number: E17DI0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention