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

Model Number	71340007
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported as the surgeon began to tension the cable after following the protocol on how to pass it, the cable began to fray and split.Nothing visually was causing the problem.The cable screw was unlocked.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Factors and/or potential probable causes that could contribute to the reported event have been identified to including but not limited to over-stressing, overloading, and user error.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 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
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8761644
• Report Number: 1020279-2019-02610
• Device Sequence Number: 16803690
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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 Model Number: 71340007
• Device Catalogue Number: 71340007
• Device Lot Number: 19CSM0492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1