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

Catalog Number 71340007

Device Problems Defective Component (2292); Connection Problem (2900)

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

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that during use, outside the patient, the accord tensioner failed so it could not be used.There was a delay between 0- 30 mins.Another s&n device was used to finish the procedure.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, the device failed during use outside the patient.Per communications, the delay was less than 30 minutes and the procedure completed with a smith and nephew backup device.Since there was, no alleged harm to the patient, no further clinical/medical assessment is warranted at time.Should additional medical information be provided, this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Without sufficiently relevant information about the device alleged fault or malfunction, no probable cause can be delineated at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 10192446
• MDR Text Key: 196379535
• Report Number: 1020279-2020-02709
• Device Sequence Number: 1
• Product Code: JDQ
• 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
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71340007
• Device Lot Number: 19GSM0454
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other