MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL TRIAL SPACER 10MM X 28MM 11MM HEIGHT; TEMPLATE

Catalog Number 03.812.311

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record 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

It was reported that on (b)(6) 2019, a transforaminal posterio atraumatic lumbar (t-pal) small trial implant cage 11mm and 10mm in height respectively broke off on its round tip during a one level fixation procedure.The broken part got stuck in an unknown t-pal inserter, however, it was taken off with the help of the sales consultant to loosen the part through demonstration.The surgery was completed by using a new smaller trial implant.Thus, there was a surgical delay of about 30 minutes.Patient outcome was stable.Concomitant device reported: unknown t-pal inserter (part# unknown, lot# unknown, quantity 1).This complaint involves (2) devices.This report is 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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.812.311, lot: 7542757, manufacturing site: hägendorf, release to warehouse date: 25.Aug.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was conducted.Visual inspection: the t-pal instrument is in a used condition with slight scratches.The ball at the end of the inner shaft is broken off.The broken of part was not returned for investigation dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.However the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.The used material was stainless steel 1.4028 as required and the measured harness was with 49-52 hrc within the specification of 48-52 hrc.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.The t-pal 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.Therefore, we can confirm the visible damages are not from any manufacturing non-conformity.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 TRIAL SPACER 10MM X 28MM 11MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8698070
• MDR Text Key: 148171558
• Report Number: 8030965-2019-65303
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819420618
• UDI-Public: (01)07611819420618
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.311
• Device Lot Number: 7542757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS