MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM9MM HEIGHT; TEMPLATE

Catalog Number 03.812.309

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that while inspecting field equipment set, the ball-tip at the end of the t-pal trial spacer (03.812.309) was discovered missing.The fragment was not found.There were no issues with the device prior to discovery.There was no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date is unknown.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the returned trial spacer was manufactured on 07oct10 and was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.Testing using t-pal, trial, large, 10 (03.809.972), which is made of the same material and has the same dimensions of the subject proximal ball tip of the subject returned trial spacer was completed and indicated that when used properly the trial spacer is capable of withstanding worst case scenario loading of 6.7kn, which has a security factor of 1.34 for testing the connection of the trial to the applicator.The t-pal technique guide states that after using the trial spacer to determine the appropriately sized spacer and ensuring that the applicator is in the pivoting position, the slap hammer is to be removed.Based on the provided guidance, the process of removing the trial spacer from the applicator must occur after the slap hammer is removed.The technique guide states that the security ring must be pushed down so that the green line is no longer visible, then the applicator knob needs to be turned counterclockwise until the knob touches the ring, finally the button on the applicator knob needs to be pressed to remove the trial spacer.The cadaver and lab testing proved that when used properly the trial spacer is capable of withstanding worst case scenario loading of 6.7kn, however it is possible that if the trial spacer detachment process is begun prior to using the slap hammer to remove the trial spacer from the disc space, the ball shaped connecting tip on the proximal end of trial spacers will not be adequately secured within the trial spacer applicator/knob assembly, which would cause the tip to experience off-axis loading which it is not designed to withstand.Considering the results of the load testing it is possible that the cause of the sustained damage involved exposing the ball shaped connecting tip to forces it was not designed to withstand, which would occur if the trial spacer detachment process was initiated prior to slap hammer usage and the connecting ball tip was not properly secured.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 TRIAL SPACER 10MM X 28MM9MM 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: 4744744
• MDR Text Key: 22067536
• Report Number: 3003875359-2015-10201
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 03.812.309
• Device Lot Number: 3572923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• 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