MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES; CERCLAGE FIXATION CABLE

Model Number 400-798

Device Problem Break (1069)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

This report is a follow-up to an already existing report.The distributor of this product incorrectly identified their self as the manufacturer of this device and submitted report number, 2939274-2019-58142, on their behalf.Three follow-up requests were sent from the distributor to the customer in efforts to obtain additional occurrence information.To date no further information was obtained.It remains unknown if a revision surgery took place.Current patient condition remains unknown.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 additional information become available at a later date.

Event Description

It was reported to rti surgical on 1/09/2020 that an abnormal radiographic evaluation confirmed a hardware failure approximately 67 days post-operatively.Index surgery was performed on (b)(6) 2019 for an intra-operative femur fracture.It was confirmed on (b)(6) 2019 that a hardware failure took place at the fracture site, as well as angulation of the fracture.Although imaging confirmed a hardware failure, it remains unknown which specific piece of hardware failed as there were nine (9) devices implanted in total.Radiographic images could not be obtained by rti surgical.

• Brand Name: CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES
• Type of Device: CERCLAGE FIXATION CABLE
• 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
• MDR Report Key: 9667676
• MDR Text Key: 205519949
• Report Number: 1833824-2020-00006
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992616
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 400-798
• Device Catalogue Number: 298.801.01S
• Device Lot Number: P298568
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR