MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH IMPLANT INSERTER SH CONNECTION; INTERVERTEBRAL 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

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 at the beginning of (b)(6) 2019, there seemed to be an issue with a transforaminal lumbar interbody fusion (tlif) implant inserter.There was (potential) patient injury.This report is for a tlif insertion instrument.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(4).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.Upon visual inspection of the returned device, it was observed that the distal end of the device was broken.No other issues were identified with the returned components of the device.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.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.

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.H10 additional narrative: b5, d11: added concomitant device.E1: added reporter's address.H11 corrected data: b5: corrected event description.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 netherlands 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.Th inner shaft of the inserter broke at the designed point high inside the outer shaft.No further information was provided.Concomitant device: implant inserter sh connection (product code: tft30101, lot#: e18di0449 qty: 1).This is report 2 of 9 for complaint: (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.H10 additional narrative: h6: code 3191 used to capture surgical intervention.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: IMPLANT INSERTER SH CONNECTION
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• MDR Report Key: 9460205
• MDR Text Key: 185736552
• Report Number: 3013730328-2019-00049
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775592
• UDI-Public: (01)04260557775592
• Combination Product (y/n): N
• PMA/PMN Number: K172888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: E17DI0680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT INSERTER SH CONNECTION
• Patient Outcome(s): Required Intervention