MAUDE Adverse Event Report: SYNTHES GMBH \; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	03.812.520
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in switzerland as follows: it was reported that on (b)(6) 2023, after the t-pal cage (ti) was positioned between the vertebral bodies l5-s1, the surgeon decided to take the tlif cage back a little bit ¿ as the cage came to lie a little tightly against the anterior plate.The cage was already rotated by 90° at this time.When striking back the advanced applicator, the well-fitting implant has detached from the instrument.The cage could no longer be grasped with the removal instrument.The cage is positioned at the anterior end plate.There was no fixation with dorsal screws, as planned.There was a surgical delay.There were no fragments generated.This report involves one (1) t-pal advanced applicator handle.This is report 1 of 3 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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10 therapy date: (b)(6) 2023.E3: reporter is a j&j employee.H3, h4, h6: 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.
Event or Problem Description
This is report 1 of 5 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.H3, h4, h6: part: 03.812.520, lot: 58p8777, manufacturing site: haegendorf, release to warehouse date: june 23, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 t-pal advanced applicator handle presented no damage or defects.A functional test with mating device (03.812.521) t-pal advanced applicator inner shaft assembled and disassembled both devices as intended.A dimensional inspection was not performed for the t-pal advanced applicator handl since it was not applicable.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 observed condition of the t-pal advanced applicator handle would not 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.Drawing/specifications reviewed the source controlled drawings reflecting the current and manufactured revisions were reviewed.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: \
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16894611
• Report Number: 8030965-2023-05929
• Device Sequence Number: 6174119
• Product Code: MAX
• UDI-Device Identifier: 10705034821078
• UDI-Public: 10705034821078
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181231
• 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: 03.812.520
• Device Catalogue Number: 03.812.520
• Device Lot Number: 58P8777
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 06/22/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED APPL INNER SHAFT; ADVANCED APPL INNER SHAFT; ADVANCED APPL OUTER SHAFT; UNK - CAGE/SPACERS: T-PAL; UNK - PLATES: SPINE; UNK - SCREWS: SPINE-US
• Patient Age: 52 YR
• Patient Sex: Unknown