MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 12MM X 32MM10MM HEIGHT; TEMPLATE

Catalog Number 03.812.510

Device Problem Break (1069)

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

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported that after a trial was loaded, it was noticed to be moving and turning.The handle was loosened to check and the trial fell out.This happened twice.After further inspection and after pulling the knob off of the handle, a piece of a trial fell on the floor after an attempt was made to hammer it out.There was a 20-25 minute surgical delay.Other handles were utilized to successfully complete the procedure with no harm to the patient.There were no fragments left in the patient.There was no patient harm; outcome was successful.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.No nonconformance 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.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product development evaluation was performed.Two applicator handles were returned in good condition with slight wear consistent with normal use.Two t-pal trial spacers were returned with the ball portion that connects to the knob broken off and not returned.The trial and shaft has scratches consistent with normal use.The trial spacers are loaded into the handle and connect to the applicator knob.The assembled instrument is then inserted into the disc space to determine the best size for the t-pal implant.Technique guide j9931-c instructs the surgeon to start conservatively when trialing.The slap hammer slides onto the applicator to assist in removal of the trial.Product drawings (b)(4) were reviewed.The trials were returned broken with the knob portion that connects to the applicator missing.The hammer provides the force necessary to remove the trial spacer.The broken portion from the trial is likely a result of the impact force generated from the slap hammer during a previous procedure.Testing has been conducted to evaluate the instrument¿s connection to the trial during removal ((b)(4)).The test was based off of forces measured during cadaver testing which determined normal loads for trial removal due to hammering to be about 3kn and in extreme cases up to 5kn (for when too large of trial is inserted).The test conducted produced loads of 6.7kn allowing for a 1.34 factor of safety.After the test, a visual inspection of all articles found no signs of damage or wear.The complaint condition is confirmed as both trials were returned broken at the end which connects to the applicator knob.Mechanical testing shows that the instrument can withstand the maximum 5kn seen in cadaver labs.The root cause for this complaint could not be identified.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 12MM X 32MM10MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4336471
• MDR Text Key: 5179407
• Report Number: 3003875359-2014-10421
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.510
• Device Lot Number: 7886620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2012
• 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
• Patient Age: 49 YR