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

Catalog Number 71340007

Device Problems Break (1069); Material Separation (1562)

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

Event Date 07/24/2018

Event Type  malfunction  

Event Description

It was reported that metal threads unbraided when the surgeon has tightened and the cable broke.

Manufacturer Narrative

The associated accord 2.00 mm cobalt chrome cable with clamp was returned and evaluated.A visual inspection of the device confirmed the stated failure.The cable showed very visible signs of unbraiding and some of the strands, where the unbraiding occured, appeared to be cut.The device was manufactured in 2018.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.Our investigation could not determine a specific cause of the failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical analysis noted that although, the retained unbraided threads are comprised of a biocompatible material, it is unknown if micromotion and/or migration of the retained pieces are likely as their locations are unknown.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted at this time.This investigation could not verify or identify any evidence of product contribution to the reported problem.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.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 road; memphis TN 38116
• MDR Report Key: 7806651
• MDR Text Key: 118101589
• Report Number: 1020279-2018-01592
• 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
• Report Date: 02/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71340007
• Device Lot Number: 18DSM0427
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 02/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1