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 Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

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.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 cranial side of the trial spacer broke.No surgical delay or patient consequence reported.Concomitant device reported: unknown t-pal outer shaft (part # unknown, lot # unknown, quantity 1).This report is for one (1) t-pal trial spacer 10mm x 28mm 11mm height.This is report 1 of 1 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, h6: part number: 03.812.311, lot number: 7737852, manufacturing site: haegendorf, release to warehouse date: 31.Jan.2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the ball at the end of the inner shaft is broken off.The broken off part was not returned for investigation.In general, the t-pal instrument is in a used condition with slight scratches.Dimensional inspection: because of the damage and the missing broken part, it is not possible to measure the relevant dimensions anymore.However, the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document/specification review: drawings (complete part) and (clamp shaft) were reviewed during this investigation.The returned t-pal instrument was manufactured in january 2012 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.The sub-component 60051594 (fork shaft) is not lot tracked.Therefore, the last three potential work orders (b)(4) that were produced prior to lot 7737852 were reviewed.The review has shown that with 1.4028 the correct material was used and that the hardness was within 48-52 hrc and according to the specification.Summary: our investigation has shown that the complaint condition is confirmed as the device was found broken.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Because of the damage and the missing broken part, it is not possible to measure the relevant dimensions anymore.Therefore, we can confirm the visible damages are not from any manufacturing non-conformity.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 10785083
• MDR Text Key: 214555024
• Report Number: 8030965-2020-08547
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: 7737852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - T-PAL OUTER SHAFT; UNK - T-PAL OUTER SHAFT