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

Catalog Number AET30101

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 australia as follows: it was reported that on (b)(6) 2023, during the case, the spine surgeon was trying to distract the disc space for alif case.The distractor thread at the distal end of the instrument was damaged (looked bent) so it would not thread/lock properly for distraction.They managed this by having the access surgeon to hold and tighten the distractor manually without threading the locking mechanism.During this same case, when the surgeon was inserting the cage with the cage inserter.The cage was malleted in as per usual process.When the surgeon went to undo the inserter from the cage to disengage.The inserter spindle at the distal end would not turn.After multiple attempts, the surgeon removed the cage altogether with the inserter.We had another inserter in the set as well as another same size implant.Case was completed with 5 minutes delay with no adverse to patient reported.This report involves one (1) implant inserter sh connection.This is report 3 of 3 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.H10 additional narrative: h3, h6: part # aet30101 lot # e19di1200 supplier: eit - batch1: lot qty of 360 units were released on 05 jun 2020 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 implant inserter sh connection was found the alif hi h 12mm 10deg s stuck on the tip.A functional test was made trying to disassemble, the devices cannot be disengaged.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the implant inserter sh connection would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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 WITH 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; GM
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19004634
• MDR Text Key: 338980785
• Report Number: 3013730328-2024-00040
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557774786
• UDI-Public: (01)04260557774786
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AET30101
• Device Lot Number: E19DI1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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: ALIF HI H 12MM 10DEG S; UNK DISTRACTION INSTRUMENTS: EIT