MAUDE Adverse Event Report: RTI SUGICAL RTI SURGICAL PEDICAL TARGETING TROCAR

Model Number	04-JAMTROCAR-08
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
These trocar instruments were returned to rti surgical for evaluation.A review of the dhr was done and these instruments were manufactured to specifications.There was no patient injury reported.This is report #2 of 2.Report #1 can be found on mdr 1833824-2018-00021.
Event or Problem Description
It was reported to rti surgical that a surgeon broke the handles off of two trocar instruments during a surgery.Because the patient had hard bone the surgeon had to drill to access the bone.There was a 60-minute delay of surgery with no patient effect.

• Brand Name: RTI SURGICAL PEDICAL TARGETING TROCAR
• Common Device Name: TROCAR
• Manufacturer (Section D): RTI SUGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 7583440
• Report Number: 1833824-2018-00022
• Device Sequence Number: 1979958
• Product Code: MNI
• UDI-Device Identifier: 00846468049348
• UDI-Public: (01)00846468049348(10)145836
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 04-JAMTROCAR-08
• Device Catalogue Number: SAME
• Device Lot Number: 145836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1