MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL ADVANCED APPLICATOR INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 03.812.521

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 instrument was no longer able to hold the t-pal in a stable manner.No surgical delay reported.There was no adverse patient consequences.Another instrument was available, and the procedure was finished successfully.Concomitant device reported: unknown cage tpal (part# unknown, lot# unknown, quantity 1).This report is for one (1) t-pal advanced applicator inner shaft.This is report 1 of 3 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.Investigation summary investigation selection, investigation site: cq zuchwil, selected flow: device interaction/functional.Visual inspection: the received inner shaft is in a very used condition.The arms of the fork are bent outward, there are stress marks at the outside of the implant holder visible and both tips of the rounded sections are flattened/worn.The cut-in at the shaft is discolored, the protective layer is worn away.The head at the end of the shaft has wear marks.Functional testing: due to the very used condition of the implant holding section a proper function of the device is not ensured anymore as the worn area at the tip has an influence on the holding force of the device.Investigation conclusion: after a visual inspection per guidance provided in windchill document # 0000277191, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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.Device history lot part: 03.812.521, lot: 3l09323, manufacturing site: hägendorf, release to warehouse date: aug 13, 2019.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.

• Brand Name: T-PAL ADVANCED APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10763730
• MDR Text Key: 213923691
• Report Number: 8030965-2020-08427
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07612334143785
• UDI-Public: (01)07612334143785
• 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
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.521
• Device Lot Number: 3L09323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVANCED APPL OUTER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL; ADVANCED APPL OUTER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL