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

Catalog Number	03.812.520
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported patient underwent a transforaminal lumbar interbody fusion (tlif) (l4/5) for spondylolisthesis on (b)(6) 2024.In the surgery, when the surgeon turned the inserter down to attach it to the cage, it fell to the floor where the shaft slid straight out.A new product was used.The surgery was completed successfully with no surgical delay.After the surgery, it was confirmed that the tip of the handle side of the shaft was missing, which remained inside the handle and could not be grasped at all.It is unknown at what point the breakage occurred.Patient was stable.This report is for a 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: h3, 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.
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: the product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that there were no damage or defect with the advanced appl outer shaft, only was observed a fragment of the proximal coupling connection mating device (advanced appl inner shaft) stuck on the mating hole (applicator knob).Broken condition was not observed and no other issues were identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.Functional evaluation was not performed due to post manufacturing damage of the mating device.The overall complaint was not confirmed as the observed condition of the advanced appl outer shaft would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.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.Device history review (dhr): part number: 03.812.520, lot number: 29p0562, manufacturing site: hägendorf, release to warehouse date: 06-jan-2020.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 HANDLE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19713459
• Report Number: 8030965-2024-08464
• Device Sequence Number: 20984683
• Product Code: MAX
• UDI-Device Identifier: 07612334143778
• UDI-Public: (01)07612334143778(11)200106(10)29P0562
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• 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 Catalogue Number: 03.812.520
• Device Lot Number: 29P0562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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; APPLICATOR KNOB
• Patient Sex: Unknown