MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE MIS; STREAMLINE MIS, CANNULATED TAP, 05.5MM

Model Number	04-CANNTAP-55
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned at the time of this report.A device history review was completed and confirmed the device met specification prior to shipping.
Event or Problem Description
During surgery the surgeon was backing out the canntap and he heard it break.It took an hour for the surgeon to remove the tip from the patient.No patient injury.

• Brand Name: PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE MIS
• Common Device Name: STREAMLINE MIS, CANNULATED TAP, 05.5MM
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 8088720
• Report Number: 1833824-2018-00036
• Device Sequence Number: 19207886
• Product Code: NKB
• UDI-Device Identifier: 00846468050245
• UDI-Public: (01)00846468050245(10)223073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• 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
• Report Date (Section B): 11/20/2018

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-CANNTAP-55
• Device Catalogue Number: SAME
• Device Lot Number: 223073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1