MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) STREAMLINE CCCIPITO-CERVICO-THORACIC SYSTEM, STANDARD TAP; BONE TAP

Model Number 26-OCPTAP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Instrument was returned to pioneer surgical technology for evaluation.Simulation testing was done as well as a complete inspection of the device and the tip functioned and was found to be within specifications.

Event Description

During a posterior fusion surgery the surgeon had difficulty getting the taps to start.After several attempts the surgeon chose to use another manufacturer's taps.This delayed surgery for 35 minutes.This delay did not have any effect on the patient and surgery was completed.

• Brand Name: STREAMLINE CCCIPITO-CERVICO-THORACIC SYSTEM, STANDARD TAP
• Type of Device: BONE TAP
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 5792083
• MDR Text Key: 50239400
• Report Number: 1833824-2016-00025
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 26-OCPTAP
• Device Catalogue Number: 26-OCPTAP
• Device Lot Number: 130790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1