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

Catalog Number	71340007
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that metal threads unbraided when the surgeon has tightened and the cable broke.
Additional 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
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7806651
• Report Number: 1020279-2018-01592
• Device Sequence Number: 1663468
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71340007
• Device Lot Number: 18DSM0427
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 02/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1