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

Catalog Number	71340007
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device released during procedure.Delay over 2 hours, back up available, no injury to patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the accord cable with clamp indicated some minor damage to the connector and fraying of the wire.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 complaint history did not reveal additional complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; 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: 7929013
• Report Number: 1020279-2018-02032
• Device Sequence Number: 11241451
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2019

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: 18EM11017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018; 09/06/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/05/2018; 01/29/2019
• 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: Other
• Patient Age: 45 YR