MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.003

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), 03.812.003 / lot number 8513932, manufacturing date: 03.Sep.2013, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) reported that two t-pal spacer applicator inner shafts no longer hold/retain the implant properly.This issue was discovered outside of surgery.There was no patient involvement.No additional information is available.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product investigation summary: the returned devices were examined and in each case the proximal coupling head was found to be broken and not returned.This failure mode would produce the reported complaint condition; as such, the complaint is confirmed.The returned t-pal applicator inner shafts are utilized in the t-pal (transforaminal posterior atraumatic lumbar) system.After trialing, the applicator inner shaft is installed into the applicator handle until the release button clicks into place.The appropriate spacer is attached by rotating the knob clockwise until the security ring clicks into position displaying a green band.The knob can then continue to be rotated clockwise until tight; the implant will not pivot in this position.The implant can then be advanced into the intervertebral disc space with light hammering.Once in position the applicator knob is rotated counterclockwise until it stops at the security ring, allowing the implant to pivot.The implant can be advanced into the final position with light controlled hammering.Once the implant is in position, it can be detached by pushing the security ring down and simultaneously turning the applicator knob counterclockwise until it stops; the applicator can then be removed from the spacer.The returned inner shafts were examined and in each instance the proximal coupling head was found to be broken.The distal portions of the devices were found to be intact, with minimal deformation consistent with use.The following product drawings for the inner shaft were reviewed during the investigation.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.Endurance testing (insertion and removal) was completed with no functional failures observed after 100 simulated application cycles.Dynamic impact loading was benchmarked from cadaver testing where loading during insertion was measured at approximately 10kn in a normal case (appropriate implant/trial size selected).The received failure mode is consistent with impaction while the handle (03.812.001) security ring is pressed forward; this would concentrate impaction forces on the proximal coupling ball tip.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.

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5434792
• MDR Text Key: 38165001
• Report Number: 3003875359-2016-10098
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Device Lot Number: 8513932
• Other Device ID Number: (01)07611819414600(10)8513932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2013
• 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