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 Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2020 during an unknown procedure, the surgeon was implanting the device, tapped with mallet, and the implant pivoted.Once the surgeon positioned the implant and had x-ray verify the ap and lateral position of cage, the surgeon then tried to remove implant from the inserter.The inserter became detached from the shaft.Further investigation showed at the proximal end of shaft, the ball had sheared off the shaft and retained in the applicator knob.There was a surgical delay of five (5) minutes.The procedure was successfully completed with another similar product.There was no patient consequence.Concomitant device reported: unk- applicator outer shaft (part #: unknown lot # unknown, quantity 1); unk - hammer (part #: unknown lot # unknown, quantity 1); unk - plate /cage tpal (part #: unknown lot # unknown, quantity 1).This report is for one (1) t-pal spacer applicator inner shaft.This is report 2 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: d10, h3, h6.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Reviewing attached picture, the breakage of the distal end of the device can be confirmed.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part: 03.812.003.Lot: 8961731.Manufacturing site: hägendorf.Release to warehouse date: july 18, 2014 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 03.812.003, lot: 8961731, manufacturing site: hägendorf, release to warehouse date: 18.July 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection the spherical end of the applicator inner shaft is broken off; the broken off part is still jammed in the applicator knob.The instrument presents surface wear consistent with use.Dimensional inspection: could not be performed due to the damage incurred.Drawing specification review: drawing was reviewed to verify the relevant dimension, material and hardness of the clamp shaft.This sub-component is not lot tracked.Therefore, the last three potential work orders that were produced prior to lot 8961731 were reviewed.The review has shown that the correct material was used and that the hardness was within the specification.Summary: the returned applicator inner shaft was examined, and the complaint condition was able to be confirmed.The review of the production history revealed that this instrument was manufactured in july 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Furthermore, these instruments are function checked with the mating parts per 100% before they leave the manufacturing site.No manufacturing related issues that would have contributed to this complaint were found; the damage occurred is determined to be post production/acceptance criterias.The t-pal applicator instruments are designed and produced to withstand normal forces during a surgery.As every surgeon has a different tactile feeling/feedback and forces can vary, the inner shaft has a predetermined breaking point on the proximal end.Whenever a certain axial force is being achieved the instrument should break rather on the proximal end than on the distal end.This allows the surgeon to dismantle the instrument and remove it safely with no patient contact to any broken parts.As every t-pal case is equipped with two inner shafts and two knobs the surgery should in case of a breakage be continued without difficulties.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 10374191
• MDR Text Key: 201906957
• Report Number: 8030965-2020-05706
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: 8961731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE