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 Codes	Pain (1994); Injury (2348)
Date of Event	07/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient visited the hospital for diagnosis and treatment because of pain after got sprain of right thigh because of body instability.External fixation with support plate was performed, and lannaconitine was injected for analgesia in emergency department, after which the patient was admitted with diagnosis of invalid internal fixation after surgery for right femoral prosthesis peripheral bone fracture in 2017.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The devices were returned in the complaint for the revision.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 peri-prosthetic 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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• 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: 7914052
• Report Number: 1020279-2018-01942
• Device Sequence Number: 14037867
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 04/02/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 58