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

Model Number	PET30102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in portugal as follows: it was reported that on (b)(6) 2023, while tightening the cage into the inserter, the internal shift broke and the surgeon could not remove the cage.The inserter was not inside the patient during this time.Procedure was completed successfully with fifteen(15) minutes surgical delay.Surgeon used another inserter to complete the procedure.No fragments were generated and no medical intervention.This report is for one (1) inserter s-hammer connection.This is report 2 of 2 for complaint (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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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: 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.D10: date of concomitant therapy is (b)(6) 2023.
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.H10 additional narrative: h3, h4, h6: part: pet30102 lot: e19di1386 supplier: eit ¿ batch1: released on 29 may 2020 with no discrepancies.No nonconformance reports (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 there was no damage or defects with the inserter sh connection.A dimensional inspection for the inserter sh connection was not performed as is not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the inserter sh connection was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -pet30102 inserter sh connection 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.B5.
Event or Problem Description
This is report 2 of 3 for (b)(4).

• Brand Name: INSERTER S-HAMMER CONNECTION
• 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; 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: 16382974
• Report Number: 3013730328-2023-00028
• Device Sequence Number: 20273427
• Product Code: MAX
• UDI-Device Identifier: 04260397088050
• UDI-Public: (01)04260397088050
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PET30102
• Device Catalogue Number: PET30102
• Device Lot Number: E19DI1386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 04/20/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/17/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POST IBF HI H 9MM 8DEG 26/9
• Patient Sex: Female
• Patient Weight: 70 KG