MAUDE Adverse Event Report: RTI SURGICAL 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Model Number	298.801.01S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is attorney.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2017, patient status post mechanical fall with complaints of right leg pain and inability to ambulate.Radiographic imaging identified a periprosthetic femoral shaft fracture indicating the patient for the aforementioned surgical stabilization procedure.On (b)(6) 2017, patient underwent an open reduction internal fixation of femur right side.On (b)(6) 2018, patient was still having pain and x-rays revealed broken plate and femoral non-union.Patient had evaluation and management of right hip pain.She was seen by other surgical team on (b)(6) 2018 and discussed revision orif vs pfr/revision arthroplasty.On (b)(6) 2019 x-rays revealed the plate is broken as well as cerclage cables at the level of the fracture site.The hardware obscures portions of the fracture.Assessment of the degree of bone bridging is difficult to assess.Mild varus angulation at the fracture level was also noted.This complaint involves two (2) devices.This report is for one (1) 1.7mm cable with crimp 750mm-sterile.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: device history lot manufacturing location: supplier rti surgical / inspected, packaged and released by: monument release to warehouse date: 05-jan-2017 expiration date: 30-sep-2021 part number: 298.801.01s, 1.7mm cable with crimp 750mm -sterile lot number: p257556 this lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d6, h6: note: following investigation was performed by the supplier.The supplier stated "numerous cables were used for what appears to be prophylactic banding.This would have been to prevent the bone from fracturing from the forces of the hip stem being implanted.It looks like the plate (not our product) has fractured near the distal end of the hip stem which is common with these types of surgeries on patients with compromised bone quality.Also, it looks like the cables are still intact and didn't fail as a result of the fracture.The overall complaint was not confirmed for the 1.7mm cable with crimp 750mm-sterile.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Updated event description: on (b)(6) 2017, patient status post mechanical fall with complaints of right leg pain and inability to ambulate.Radiographic imaging identified a periprosthetic femoral shaft fracture indicating the patient for the aforementioned surgical stabilization procedure.On (b)(6) 2017, patient underwent an open reduction internal fixation of femur right side, fixation was then obtained with multiple cables made along synthes lateral plate.On (b)(6) 2018, patient was still having pain and x-rays revealed broken plate and femoral non-union.Patient had evaluation and management of right hip pain.She was seen by surgeon's team on (b)(6) 2018 and discussed revision orif vs pfr/revision arthroplasty.On (b)(6) 2019 x-rays revealed the plate is broken as well as cerclage cables at the level of the fracture site.The hardware obscures portions of the fracture assessment of the degree of bone bridging is difficult to assess.Also noted mild varus angulation at the fracture level.On (b)(6) 2019, the patient underwent two component revision, right total hip, radical excision of proximal 21cm of right femur and prophylactic stabilization of distal right femur with plate/screw/cable construct due to failed right total hip replacement with vancouver c periprosthetic fracture nonunion with broken lateral femoral plate.

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 10080776
• Report Number: 1833824-2020-00046
• Device Sequence Number: 3468470
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: (01)10886982182500
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 298.801.01S
• Device Catalogue Number: 298.801.01S
• Device Lot Number: P257556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 03/22/2023; 04/28/2023
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/18/2020; 04/06/2023; 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG