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

Catalog Number	03.812.003
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.
Event or Problem Description
It was reported that on (b)(6) 2021 intraoperatively the round end of the applicator inner shaft broke off.Procedure was completed successfully and another applicator inner shaft was used.No negative patient consequences and no fragments were generated.This report is for one (1) t-pal spacer applicator inner shaft.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: b5.Investigation summary: visual inspection: the applicator inner shaft (part# 03.812.003, lot# 4l62198, qty# 1) was returned and received at us cq.Upon visual inspection, it is observed that the spherical end of the applicator inner shaft is broken off and the broken part was not returned.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post manufacturing damage.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the applicator inner shaft (part# 03.812.003, lot# 4l62198, qty# 1).A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.Device history lot.Part number: 03.812.003.Lot number: 4l62198.Manufacturing site: haegendorf.Release to warehouse date: 13 november 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.Planned non-product non-conformance was opened to manage all work orders (wo) and purchase orders (po) which were in wip during the cutover phase from old erp to new erp.This nc is affecting dhr reconciliation only and, for this reason, products are not impacted.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.Corrected data: d9, h3, h6.
Event or Problem Description
There was a surgical delay of five (5) minutes.

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12518330
• Report Number: 8030965-2021-07935
• Device Sequence Number: 4291036
• Product Code: MAX
• UDI-Device Identifier: 07611819414600
• UDI-Public: (01)07611819414600
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 03.812.003
• Device Lot Number: 4L62198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1