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

Catalog Number 71340007

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 12/31/2017

Event Type  Injury  

Event Description

It was reported per stewart et al, "trochanteric fixation with a third-generation cable-plate system: an independent experience", that a medical intervention was required due to failure of cable plate device.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and the failures, of the 10 cable-plate systems were; 6 due to broken wires and 4 from cable slipping from clamp.Of these the associated activities and compliance of the patients were not reported.It was also suspected in the paper that the patients ages were an average 10 years older than a paper by patel (s.Patel, j.A.Soler, m.El-husseiny, d.J.Pegg, j.D.Witt, f.S.Haddadtrochanteric fixation using a third-generation cable device-minimum follow-up of 3 years) which did not show any cable-plate failures and this could indicate bone quality played a role.The root causes, of 6 failures are likely associated with non-union reported present from 4.8-36.6 months.The other 4 failures were not associated with non-union but 3 were still removed and the root cause of the failure cannot be concluded from the information provided in the publication.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.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7737152
• MDR Text Key: 115643618
• Report Number: 1020279-2018-01448
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• 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: ASKU
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention