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

Model Number PET30102

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 05/01/2023

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.H6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 depuy synthes reports an event in portugal as follows: it was reported that on (b)(6) 2023 during spinal procedure both posterior lumbar interbody fusion (plif) inserters had internal thread damaged and the assembly was done with difficulty.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence reported.This report is for one (1) inserter sh connection this is report 2 of 2 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: part # pet30102; lot # e20di0341; supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on 16.Dec.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 device associated with this report was returned to depuy synthes for evaluation.The device inserter sh connection shows stripped condition in the tip.No other defect is seen.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed for the inserter sh connection as it is not applicable to the complaint condition.A complete functional test was unable to performed since the notches on the medial and lateral sides of the implant were not received, however; interactional test was performed with the t-handle inserter and it fits as intended.The complaint condition was not able to be replicated.The overall complaint was confirmed as the observed condition of the inserter sh connection would contribute to the alleged device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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.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: 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
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; GM D-78573
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 17132616
• MDR Text Key: 317212071
• Report Number: 3013730328-2023-00071
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260397088050
• UDI-Public: (01)04260397088050
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K172888
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PET30102
• Device Catalogue Number: PET30102
• Device Lot Number: E20DI0341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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: T-HANDLE INSERTER.
• Patient Age: 45 YR
• Patient Weight: 75 KG