MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) GTR IMPLANT SET, EXT 4-H, W/CABLE, STERILE; GREATER TROCHANTERIC REATTACHMENT DEVICE

Model Number 401-084

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted in the patient and is not available for evaluation.A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility.This report will be updated should information become available at a later date.

Event Description

It was reported to rti surgical that during a surgery on (b)(6) 2020, this device was implanted after it had already expired.The rep reported that the surgeon was aware that the device was expired prior to implanting it.

• Brand Name: GTR IMPLANT SET, EXT 4-H, W/CABLE, STERILE
• Type of Device: GREATER TROCHANTERIC REATTACHMENT DEVICE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 11269258
• MDR Text Key: 232179232
• Report Number: 1833824-2021-00009
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2020
• Device Model Number: 401-084
• Device Catalogue Number: SAME
• Device Lot Number: 56613916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1