MAUDE Adverse Event Report: SYNTHES GMBH T-PAL ADVANCED APPLICATOR INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 03.812.521

Device Problem Compatibility Problem (2960)

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

Event Date 05/03/2023

Event Type  malfunction  

Event 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 inner shaft.This is report 5 of 5 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, 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.

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: d10: date of concomitant therapy is may 3, 2023.H3, h4, h6: part: 03.812.521.Lot: 441p935.Manufacturing site: haegendorf.Release to warehouse date: november 26, 2021.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 inner shaft was bent outwards at the tip.It is reasonable to conclude that the observed condition would prevent the device from holding the mating implant properly.A dimensional inspection was not performed for the t-pal advanced applicator inner shaft since it was not applicable.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 t-pal advanced applicator inner shaft 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.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: T-PAL ADVANCED APPLICATOR INNER SHAFT
• Type of Device: 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 16954762
• MDR Text Key: 315493266
• Report Number: 8030965-2023-06316
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10705034821085
• UDI-Public: (01)10705034821085
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K181231
• 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: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.812.521
• Device Catalogue Number: 03.812.521
• Device Lot Number: 441P935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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: ADVANCED APPL INNER SHAFT; ADVANCED APPL OUTER SHAFT; ADVANCED APPL OUTER SHAFT; UNK - CAGE/SPACERS: T-PAL; UNK - PLATES: SPINE; UNK - SCREWS: SPINE-US
• Patient Age: 52 YR