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 Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.(b)(4).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) 2018, during an unknown procedure, two (2) applicator inner shafts from the t-pal case broke at the same part of insertion while inserting the cage.Surgeon had to carefully insert and impact the cage with bone punches which was not ideal.However, the cage was not optimally positioned due to the instrumentation we had available.There was a surgical delay of forty-five (45) minutes.No patient consequences reported.Patient and procedure outcome were unknown.This report is for one (1) t-pal spacer applicator inner shaft.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Relevant drawings were reviewed.No changes immediately preceding the manufacture of the device were identified.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As per the relevant technique guide, the function control of the inner shaft states that the shaft should be replaced when deformations at the groove are present.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history lot part: 03.812.003 lot: 9824907 manufacturing site: haegendorf release to warehouse date: 19.Feb.2016 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.The material was reviewed and the hardness value was confirmed to meet the specification with no non-conformance noted.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
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> investigation selection investigation site: cq zuchwil visual inspection: the cap at the end of the shaft is broken off as complained.In general is the inner shaft in a very used condition, the edges at the groove are deformed.Also at the fork are heavy sign of often and intense use visible, the levers of the fork are bent outward.Dimensional inspection: the relevant dimension at the fracture face cannot be verified anymore as the breakage occurred at the cross over.In addition is the surface is deformed, most likely by hammer blows after the breakage occurred.Material review: the used material for sub-component 60051594 was stainless steel 1.4028 as required and the measured harness was within the specification summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information the exact cause of this breakage cannot be defined.In general it can be stated that 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.Wear and tear could also have played a certain role, as the condition of received device does indicate that it was often and very intense used.No manufacturing related issue could be detected.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: 8106085
• MDR Text Key: 128415880
• Report Number: 8030965-2018-58492
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Device Lot Number: 9824907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention