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

Catalog Number 611.105.01S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Patient code (b)(4) used to capture additional medical/surgical intervention required.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 Description

Device report from (b)(6) reports an event as follows: it was reported on an unknown date that on (b)(6) 2020, the patient will undergo the revision surgery with screws and nesplon cables due to the bone quality or surgical technique issues.Previously, it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for proximal femoral fracture around the stem with the cable in question.During the surgery, the surgeon applied the 50kg tension to the cable while confirming with the surgical elevator.The surgery was completed successfully without any surgical delay.Next date to the surgery, the patient had difficulty in standing up due to the pain.2-weeks after the surgery, the surgeon confirmed that the cable part bone was torn apart and schedule for revision surgery on (b)(6) 2020.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.Concomitant product reported: unk - plates: 4.5 mm lcp proximal femur plate (product# unknown, lot# unknown, qty 1) unknown cerclage positioning pin (product# unknown, lot# unknown, qty unknown).This complaint involves one (1) device.This report is for (1) 1.7mm cocr cable with ti crimp 750mm-sterile.This report is 1 of 1 for pc (b)(4).

• Brand Name: 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11112420
• MDR Text Key: 231191656
• Report Number: 1833824-2021-00001
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819757615
• UDI-Public: (01)07611819757615
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 611.105.01S
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention