MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL ADVANCED APPLICATOR HANDLE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.520

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 during an unknown procedure on (b)(6) 2020, the implant cannot be fixated to the applicator firmly.Surgery completed with another available instrument.There was no surgical delay and adverse patient consequences reported.Concomitant device reported: t-pal advanced applicator inner shaft(part # 03.812.521, lot # 1l07297, quantity 1); cage/plate (part # unknown, lot # unknown, quantity unknown); applicator knob (part # unknown, lot # unknown, quantity 1); thoracic awl (part # unknown, lot # unknown, quantity 1).This report is for one (1) t-pal advanced applicator handle.This is report 1 of 2 for complaint (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: the device has been 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.

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.The returned t-pal instrument was forwarded to the product development center for an evaluation.The statement below is a summary of their investigation.The visual inspection showed normal wear and tear.No breakage or bending could be detected.During the functional test it could be demonstrated that the instrument works as intended according to the surgical technique.The implant could be loaded to the holder without any issues.Hence the complaint condition cannot be confirmed and based on the results of the visual investigation and the functional test, no action and no further evaluation is required.The complaint is unconfirmed for this t-pal instrument based that the article is functional as required.But the complaint is confirmed as the returned part could be verified as wear and tear.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Investigation picture are attached in the complaint file.Device history part: 03.812.520, lot: 1l83488, manufacturing site: hägendorf, release to warehouse date: 19.Nov.2018.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 HANDLE
• 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: 10112902
• MDR Text Key: 193663924
• Report Number: 8030965-2020-03887
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07612334143778
• UDI-Public: (01)07612334143778
• 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,Followup
• Report Date: 05/22/2020

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: 03.812.520
• Device Lot Number: 1L83488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/23/2020; 07/03/2020
• Supplement Dates FDA Received: 06/25/2020; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVANCED APPL INNER SHAFT; UNK - APPLICATOR KNOB; UNK - CAGE/PLATE; UNK - THORACIC AWL