MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT; TEMPLATE

Catalog Number 03.812.308

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing site: (b)(4) - manufacturing date: april 5, 2011.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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 Description

Device report from synthes europe reports an event in the (b)(6) as follows: it was reported that a patient had a transforaminal posterior atraumatic lumbar (t-pal) cage inserted during a surgical procedure on (b)(6) 2016.However, the surgeon was unable to remove the applicator shaft following cage insertion.After a few unsuccessful attempts, the surgeon removed the applicator and the cage together.The process was then re-started with the use of an alternate applicator shaft.The procedure was successfully completed on this second attempt.The procedure was extended approximately five (5) minutes.It was noted that the issue occurred two (2) other times recently.Those issues have been captured in and reported under separate complaints (b)(4).Concomitant device(s) reported: t-pal applicator outer shaft (part: 03.812.001 / lot: 9751114 / quantity: 1) and t-pal applicator knob (part: 03.812.004 / lot: 9877536 / quantity: 1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 Description

It was reported there was no patient harm and the patient status was reported as fine post-operatively.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed.The received instruments were confirmed due to the damage of the inner shaft.Manufacturing documents of both devices were reviewed and no complaint related issues were found.This event did lead to the damage of the inner shaft.During this evaluation a function test with the outer shaft and the trail implant was performed and the devices were functional as required.Based on that a product related issue at the trial implant can be excluded.It is also likely that the mentioned jamming was caused during the insertion of the cage when the angle of the applicator to the sagittal plane was below the recommended 10 degrees.Additionally an over-rotation of the cage (more than 90 degree relative to the sagittal plane) eventually caused a jamming of the t-pal cage to the applicator.In this relation, the t-pal technique guide can be mentioned: maintain 10 ¿15° between the applicator handle and the sagittal plane during implant insertion.The exact root cause of this complaint cannot be defined due to the damage of the inner shaft.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 TRIAL SPACER 10MM X 28MM 8MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5963509
• MDR Text Key: 55148597
• Report Number: 3003875359-2016-10498
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.308
• Device Lot Number: 3750668
• Other Device ID Number: (01)07611819418981(10)3750668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2011
• 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: 03.812.001: T-PAL SPACER APPLICATOR HANDLE; 03.812.004: T-PAL SPACER APPLICATOR KNOB