MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC 2.0MM COCR CABLE W/CLAMP; CERCLAGE, FIXATION

Model Number 71340007

Device Problem Break (1069)

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

Event Date 05/25/2020

Event Type  Injury  

Event Description

It was reported that during an internal fixation of femoral fracture, two accord cables were broke inside the patient.A backup device was available to complete the surgery.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that during an internal fixation of femoral fracture, two accord cables were broke inside the patient.A backup device was available to complete the surgery.No other complications were reported.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Some of the strands on the cable are fractured and frayed.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.The surgical technique for this device warns, ¿do not use another torque-limiting screwdriver handle or standard screwdriver handle as this may apply an inappropriate amount of torque to the screw head causing breakage.¿ therefore, the use of excessive torque as the likely cause of the device breakage cannot be ruled out.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: ACC 2.0MM COCR CABLE W/CLAMP
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10171577
• MDR Text Key: 195717552
• Report Number: 1020279-2020-02552
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (y/n): N
• PMA/PMN Number: K031162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71340007
• Device Catalogue Number: 71340007
• Device Lot Number: 19CSM0504
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR