MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH TLIF TRIAL INSERTER

Model Number	TFT20100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not more than the filled information was provided by complainant.Weight was best estimated.The instrument in question is a 3 part device.The hospital assembled the device incorrectly.They used parts from different devices.Therefore the outer shaft (tft20101a) has the lot number: e16di0420, the knob (tft20101b) has the lot number: e16di0567 and the lot number of the inner pin (tft20100c or tft20101c) could not be determined since the device can not be disassembled.Device was used for treatment, not diagnosis.Of information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
After completion of the case, when packing up the instrumentation, the 3 piece insertion handle was unable to be taken apart as the inner shaft appears to be jammed and subsequently is not useable.
Additional Manufacturer Narrative
Correction of additional manufacturer narrative: a1-a6: not more than the filled information was provided by complainant.Weight was best estimated.The instrument in question is a 3 part device.The hospital assembled the device incorrectly.They used parts from different devices.Therefore the outer shaft (tft20101a) has the lot number: e16di0420, the knob (tft20101b) has the lot number: e16di0567 and the lot number of the inner pin (tft20100c or tft20101c) could not be determined since the device can not be disassembled.Eit emerging implant technologies gmbh (eit) is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which eit has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, eit or its employees that the report constitutes an admission that the device, eit, 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 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.Capa 2018-aud-010 driven by an audit, performed by the parent company johnson & johnson, it was evaluated that the complaint/incident on hand needs to be reported retrospectively.

• Brand Name: TLIF TRIAL INSERTER
• Common Device Name: TRIAL INSERTER
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 8459135
• Report Number: 3013730328-2019-00016
• Device Sequence Number: 18892067
• Product Code: MAX
• UDI-Device Identifier: 04260557775561
• UDI-Public: 04260557775561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: TFT20100
• Device Catalogue Number: N/A
• Device Lot Number: E16DI0420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2017
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 60