MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) RTI SURGICAL GREATER TROCHANTERIC REATTACHMENT DEVICE LONG STERILE, W/CABLES

Model Number	401-120
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2020
Type of Reportable Event	Serious Injury
Additional 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:.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2020 that a revision surgery had taken place due to post-operative joint swelling.The index surgery was performed on (b)(6) 2019.The revision was performed on (b)(6) 2020.The product is not available for inspection.

• Brand Name: RTI SURGICAL GREATER TROCHANTERIC REATTACHMENT DEVICE LONG STERILE, W/CABLES
• Common Device Name: GREATER TROCHANTERIC REATTACHMENT DEVICE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• MDR Report Key: 10113269
• Report Number: 1833824-2020-00024
• Device Sequence Number: 14361720
• Product Code: KTT
• UDI-Device Identifier: 00846468064051
• UDI-Public: (01)00846468064051(17)240102(10)56699355
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 401-120
• Device Catalogue Number: SAME
• Device Lot Number: 56699355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization