MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH EIT PLIF STRAIGHT HANDLE

Model Number	PET00920
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information was provided by the complainant.No further remedial action/ corrective action/ preventive action/ field safety corrective action is required, as it is questionable why the surgeon spend extra effort to disconnect the instrument from pet00920 prior to finishing the surgery.The complainant explicitly states that the instrument was jammed after implant insertion.There is no direct connection between usage of pet00920 and any implant, that would explain the delay of surgery by trying to disconnect the the jammed pet00920.
Event or Problem Description
Complainant stated that an instrument was jammed in the instrument pet00920 after implant insertion.The complainant pointed out that the extra effort to disconnect the instrument from pet00920 led to a surgical delay.
Additional Manufacturer Narrative
No patient information was provided by the complainant.No further remedial action/ corrective action/ preventive action/ field safety corrective action is required, as it is questionable why the surgeon spend extra effort to disconnect the instrument from pet00920 prior to finishing the surgery.The complainant explicitly states that the instrument was jammed after implant insertion.There is no direct connection between usage of pet00920 and any implant, that would explain the delay of surgery by trying to disconnect the jammed pet00920.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 (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.

• Brand Name: EIT PLIF STRAIGHT HANDLE
• Common Device Name: STRAIGHT HANDLE
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 8460412
• Report Number: 3013730328-2019-00021
• Device Sequence Number: 13898450
• Product Code: MAX
• UDI-Device Identifier: 04260397080863
• UDI-Public: 04260397080863
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• 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: PET00920
• Device Catalogue Number: N/A
• Device Lot Number: E15DI0026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2018
• Device Age: 3 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: 50 YR
• Patient Weight: 75