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

Catalog Number 03.812.003

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown device is an instrument and is not implanted/explanted.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.A review of the device history records has been requested.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

Device report from synthes europe reports an event in (b)(6) as follows: on (b)(6) 2018, the transforaminal lumbar interbody fusion (tlif) surgery was performed at l3-l4 using the transforaminal posterior atraumatic lumbar (t-pal) system.During the surgery, the cage was inserted to the vertebral disk and then pivoted using the applicator unit.To detach the cage, the knob was turned counterclockwise to the ¿open¿ direction, but the cage could not be detached from the inner shaft.As the surgeon tried to detach the outer shaft from the inner shaft, the outer shaft could be separated from the inner shaft without pushing the small button on the knob.Finally, the surgeon was able to detach the cage from the inner shaft and successfully completed the surgery with no delay.Reportedly, there was no adverse consequence to the patient; the patient status was reported as stable.Concomitant device reported: t-pal small h9 peek (part 08.812.009s, lot unknown, quantity 1).This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.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.

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.Part: 03.812.003; lot: l378898; manufacturing site: hägendorf; release to warehouse date: 22.June 2017; the device history record shows this lot of 48 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary: investigation selection investigation site: cq zuchwil, selected flow: 2.Device interaction/functional - unable to disassemble : rm.Visual inspection: the visual inspection has shown that the returned t-pal instrument has only slight signs of wear.Functional test: after connecting the returned part with a peek implant from a demo set it can be stated that the instruments work as intended.Connecting and disconnecting the implant from the applicator could be done without any problems.The in the complaint description mentioned cage / peek implant was not returned.Therefore, no statement regarding the function in combination with the mentioned implant can be done.Dimensional inspection: as this investigation is focused in the functional issue and this was covered through the functional test performed, therefore, measurements of the features are not relevant for the complaint.Drawing/specification review: as this investigation is focused in the functional issue and this was covered through the functional test performed, therefore, drawing/specification review is not required.Summary: the t-pal instrument is rated as not confirmed, since the device has passed the functional test as described above.Unfortunately, we are not able to determine the cause of this complaint.It can be assumed that probably the angle during the removing process of the trial implant was below the recommended 10 ¿ 15 degrees between the applicator handle and the sagittal plane.This could lead to the mentioned problems as mentioned.In this relation and for more details, please refer to the current technique guide dsem/spn/0714/0145(2).Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 SPACER APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7560551
• MDR Text Key: 109800035
• Report Number: 8030965-2018-54082
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414600
• UDI-Public: (01)07611819414600
• Combination Product (y/n): N
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: L378898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1