MAUDE Adverse Event Report: Pioneer Surgical Technology Cable-Ready® Cable Grip System, Greater Trochanteric Reattachment (GTR) Device; Integral Long Greater Trochanteric Reattachment Device (GTR) w/4 Cables, 23x121m

Model Number	401-120
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event was investigated with the information provided by the complainant.The device was discarded post-explantation; therefore, an evaluation could not be performed.A device history record review did not identify any nonconformities that are present within the lot that would be related to the nature of this event.No further event information was made available regarding the origins or type of infection.The root cause cannot be established with the currently available information.
Event or Problem Description
Primary left hip procedure on (b)(6) 2016.Subsequently revised (b)(6) 2026 due to infection.Removed plate, stem, cup.Infection source unknown.Plate was taken off during stage 1 of the revision to remove all parts to clear infection.

• Brand Name: Cable-Ready® Cable Grip System, Greater Trochanteric Reattachment (GTR) Device
• Common Device Name: Integral Long Greater Trochanteric Reattachment Device (GTR) w/4 Cables, 23x121m
• Manufacturer (Section D): Pioneer Surgical Technology; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): Pioneer Surgical Technology; 375 river park circle; marquette MI 49855
• Manufacturer Contact: tamara lewis ; 375 river park circle; marquette, MI 49855 ; +1(906)226-9909
• MDR Report Key: 50436627
• Report Number: 1833824-2026-00005
• Device Sequence Number: 16053744
• Product Code: KTT
• UDI-Device Identifier: 00846468064051
• UDI-Public: 00846468064051
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K000734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: Lay User/Patient
• Device Model Number: 401-120
• Device Catalogue Number: 2232-02-05
• Device Lot Number: 56610998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female