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

Model Number	TFT20101
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information was provided by the distributor.Age and weight were best estimated.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.Per capa (b)(4) 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.
Event or Problem Description
While trying to release the trial inserter from the trial to change to another trial size, the feather key as well as the tip of the inserter pin broke off.
Event or Problem Description
Inner pin tip broke off.Eit could not perform an investigation, as the device was not received back at eit.Eit has closed the complaint.
Additional Manufacturer Narrative
A1-a6: no patient information was provided by the distributor.Age and weight were best estimated.B5: additional information added.H6: additional event problem and evaluation codes changed and added.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.Per 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: EIT 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: 8540025
• Report Number: 3013730328-2019-00033
• Device Sequence Number: 400913
• Product Code: MAX
• UDI-Device Identifier: 04260557775561
• UDI-Public: 04260557775561
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019
• Report Date (Section F): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFT20101
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2018
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 04/23/2019