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

Model Number AET20101

Device Problem Material Twisted/Bent (2981)

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 trial inserter sh connection (p/n: aet20101, lot #: e16di0283) was returned and received at us cq.Upon visual inspection, it was observed that the tip of the device was deformed.There were scratches on the device but that 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: a manufacturing-related potential cause was not suspected, therefore document/specification review was not performed investigation conclusion: the complaint condition is confirmed for the trial inserter sh connection (p/n: aet20101, lot #: e16di0283).There is no indication that a design or manufacturing issue has caused the deformation 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: aet20101 a, lot number e16di0283.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) 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 tip of the returned device was deformed.Concomitant device: implant inserter sh connection (product code: tft30101, lot #: e18di0449 qty: 1).This report is for one (1) trial inserter sh connection.This is report 6 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: h3, h4, h6: the trial inserter sh connection (p/n: aet20101, lot #: e16di0283) was returned and received at us cq.Upon visual inspection, it was observed that the tip of the device was deformed.There were scratches on the device but that has no impact on the functionality of the device.No other issues were identified with the returned components of the device.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.The complaint condition is confirmed for the trial inserter sh connection (p/n: aet20101, lot #: e16di0283).There is no indication that a design or manufacturing issue has caused the deformation 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 history lot part number: aet20101 a lot number e16di0283 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.

• Brand Name: TRIAL 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
• MDR Report Key: 9603708
• MDR Text Key: 188835762
• Report Number: 3013730328-2020-00005
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557774779
• UDI-Public: (01)04260557774779
• 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
• 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?: No
• Device Operator: Health Professional
• Device Model Number: AET20101
• Device Catalogue Number: AET20101
• Device Lot Number: E16DI0283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT INSERTER SH CONNECTION
• Patient Outcome(s): Required Intervention