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

Model Number	71340007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10171577
• Report Number: 1020279-2020-02552
• Device Sequence Number: 11342368
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2020

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 Model Number: 71340007
• Device Catalogue Number: 71340007
• Device Lot Number: 19CSM0504
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 09/22/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/18/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR