MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD 2.0MM COCR CABLE; CERCLAGE, FIXATION

Catalog Number	71340020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the cables broke inside the patient.
Additional Manufacturer Narrative
Two cables and post-operative radiographs were returned for analysis.The cables were broken in to segments, 18 and 6 inches, correlating to an original length of 24 inches.This cable is not shipped with a standalone clamp as it is intended to be used with accord trochanteric grips or accord straight plates which have clamps built into them.No other components were returned with the cables.The sem analysis clearly exhibits the cables were subjected to over tensioning.The lack of a well-defined signature of clamping device in the radiographs provided also raises questions concerning how the cable ends were connected to each other and the implanted plate.Without the use of proper clamping devices for accord, it is impossible to perform as intended.It is most likely this impacted the result described in the complaints.A clinical analysis indicated that the contributing factors to the fractured cables were the ¿over tensioning¿ and the ¿lack of proper clamping devices¿ in addition to the reported non-adherence/early weight-bearing and subsequent traumatic event in the presence of recently implanted hardware post orif of the right femoral periprosthetic fracture and the temporary ¿external fixation with support plate¿ which was performed in the interim prior to definitive treatment.The patient impact beyond the reported temporary fixation, revision, likely pain/discomfort and an expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed prior complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: ACCORD 2.0MM COCR CABLE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7862758
• Report Number: 1020279-2018-01777
• Device Sequence Number: 11124161
• Product Code: JDQ
• UDI-Device Identifier: 03596010485724
• UDI-Public: 03596010485724
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71340020
• Device Lot Number: 17LSM0155
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 58