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

Model Number	LET30100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from germany reports an event as follows: during an inspection at the loaner set department on an unknown date, it was noticed that the implant holder is broken.No surgery impact, no patient impact.This report is for an implant inserter.This is report 1 of 1 for (b)(4).
Additional 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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.
Additional 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.H6: a product investigation was conducted.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 inner shaft of the implant inserter, p/n: let30100, was broken at the threaded end.The broken fragment remains inside the handle of the device.No other problems identified.A dimensional inspection was unable to be performed due to post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the implant inserter, p/n: let30100 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.H6: a device history record (dhr) review was conducted: part#let30100 lot # e19di1312 supplier: (b)(4).Batch1: lot qty of 3 units were released on 02may 2022 with no discrepancies.Batch2: lot qty of 5 units were released on 08 march 2022 with no discrepancies.Batch3: lot qty of 1 units were released on 15 oct 2021 with no discrepancies.Batch4: lot qty of 1 units were released on 01 oct 2021 with no discrepancies.Batch5: lot qty of 10 units were released on 29sep 2021 with no discrepancies.Batch6: lot qty of 1 units were released on 10 sep 2021 with no discrepancies.Batch7: lot qty of 2 units were released on 23 aug 2021 with no discrepancies.Batch8: lot qty of 1 units were released on 23 aug 2021 with no discrepancies.Batch9: lot qty of 7 units were released on 23 aug 2021 with no discrepancies.Batch10: lot qty of 1 units were released on 23 aug 2021 with no discrepancies.Batch11: lot qty of 1 units were released on 23 aug 2021 with no discrepancies.Batch12: lot qty of 3 units were released on 19 aug 2021 with no discrepancies.Batch13: lot qty of 1 units were released on 11 aug 2021 with no discrepancies.Batch14: lot qty of 1 units were released on 09 aug 2021 with no discrepancies.Batch15: lot qty of 2 units were released on 14 july 2021 with no discrepancies.Batch16: lot qty of 1 units were released on 12 july 2021 with no discrepancies.Batch17: lot qty of 3 units were released on15 june 2021 with no discrepancies.Batch18: lot qty of 2 units were released on 23march 2022 with no discrepancies.Batch19: lot qty of 3 units were released on 11march 2021 with no discrepancies.Batch20 : lot qty of 20 units were released on 23 june 2020 with no discrepancies.Batch121: lot qty of 60 units were released on 03 june2020 with no discrepancies.Batch22 : lot qty of 40 units were released on 03 june 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.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
• Common Device Name: 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
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 14695124
• Report Number: 3013730328-2022-00043
• Device Sequence Number: 6637638
• Product Code: MAX
• UDI-Device Identifier: 04260557837733
• UDI-Public: (01)04260557837733
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LET30100
• Device Catalogue Number: LET30100
• Device Lot Number: E19DI1312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown