MAUDE Adverse Event Report: PIONEER SURGICAL RTI SURGICAL GREATER TROCHANTERIC REATTACHMENT DEVICE LONG STERILE, W/CABLES

Model Number 401-120

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to rti surgical 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.The following sections of this report have been left blank due to the information being unavailable or non-applicable: patient identifier - race, relevant tests / laboratory data, other relevant history, explant date, concomitant medical products, recall or correctional / removal number, usage of device.

Event Description

It was reported to rti on (b)(6) 2021 that the product was due to expire on (b)(6) 2020 but was implanted on (b)(6) 2021.

• Brand Name: RTI SURGICAL GREATER TROCHANTERIC REATTACHMENT DEVICE LONG STERILE, W/CABLES
• Type of Device: GREATER TROCHANTERIC REATTACHMENT DEVICE
• Manufacturer (Section D): PIONEER SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A RTI SURGICAL); 375 river park circle; marquette 49855
• Manufacturer Contact: joshua penrose ; 375 river park circle; marquette, MI 49855 ; 9062264455
• MDR Report Key: 13180479
• MDR Text Key: 285852990
• Report Number: 1833824-2021-00101
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 0084646804605
• UDI-Public: (01)0084646804605(17)201023(10)56615579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: 401-120
• Device Lot Number: 56615579
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other