MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ADVANCED APPL OUTER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.520

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that this was a posterior lumbar spinal fusion in l4-5 treating lumbar spinal canal stenosis on (b)(6) 2020.The applicator inner shaft was caught in at the back of the intervertebral disc during t-pal implant deployment.When the surgeon rotated the inner shaft, it became distorted.But later it was discovered that the shafts were not distorted.It was unknown if the surgery completed successfully.The patient outcome was unknown.Concomitant devices reported: applicator knob (part# 03.812.004, lot# unknown, quantity 1), applicator inner shaft (part# 03.812.521, lot# unknown, quantity 1), unknown tpal implant (part# unknown, lot# unknown, quantity 1).This complaint involves four (4) devices.This is report 2 of 4 for (b)(4).

Event Description

It was further reported that the surgery was completed successfully without any surgical delay.Patient outcome is reported as stable.Concomitant device reported: t-pal spacer applicator knob (part# 03.812.004, lot# unknown, quantity 1); t-pal spacer applicator handle (part# 03.812.001, lot# unknown, quantity 1); t-pal advanced applicator inner shaft(part # 03.812.521, lot # 4l18332, quantity 1); tpal implant (part# unknown, lot# unknown, quantity 1).

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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h6: part: 03.812.520, lot: 4l26074, manufacturing site: hägendorf, release to warehouse date: may 2, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection the returned outer shaft are in a sound condition, as well, and show normal signs of usage.The returned inner shafts show signs of use on the distal part of the instrument.The finger like catcher is bent.The proximal part is in a sound condition and shows normal signs of usage.Functional test the returned advanced applicator components (inner and outer shaft) were assembled according to procedure.The applicator knob was not returned; however, the performed function test did not show any irregularities.Inner shaft could be assembled with outer shaft as intended.In addition, functional test was performed per 100% at the time of manufacturing with no non-conformities documented.Dimensional inspection could not be performed due to the damage incurred.Document/specification review: the instruments were manufactured according to the specifications (part# 03.812.521 in june 2019, part# 03.812.520 in may 2019).The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Final inspection was performed per 100% on these parts as per test instruction and assembly instruction.Function check involved gripping and pivoting of implant/gauge.Summary: the returned t-pal advanced applicator outer shaft is in a sound condition and shows normal signs of use.The complaint condition of the advanced applicator inner shaft was able to be confirmed as the tip of the instrument was found to be bent.The investigation found no product related issues that would have contributed to this complaint condition.Unfortunately, we only have limited information in the complaint description.However, the damage of the inner shaft is determined to be post production/acceptance criterias.The exact circumstances are not known we therefore can only assume that not all steps of the surgical technique were followed correctly, which could potentially have led to this complaint.If, for example, the entry angle was not parallel to the vertebral endplates or the angle between the sagittal plane and the handle was not within the range of 10°-15° the detaching of the applicator inner shaft and the implant might become difficult.Further information / precaution hints can be found in the respective surgical techniques t-pal interbody system and t-pal spacer advanced applicator.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: ADVANCED APPL OUTER 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: 10102604
• MDR Text Key: 194059264
• Report Number: 8030965-2020-03786
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07612334143778
• UDI-Public: (01)07612334143778
• Combination Product (y/n): N
• PMA/PMN Number: K181231
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.520
• Device Lot Number: 4L26074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APPLICAT OUT SHAFT; APPLICATOR KNOB; T-PAL ADVANCED APPLICATOR INNER SHAFT; T-PAL SPACER APPLICATOR HANDLE; T-PAL SPACER APPLICATOR KNOB; UNKNOWN TPAL IMPANT; UNKNOWN TPAL IMPANT