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	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw which is assembled with the cramp break into the femoral bone.The doctor concerns the screw make the osteo bone damage, such as fracture.Procedure delayed less than 30 minutes.Backup device was available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical task concluded, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.The root cause of the broken device is unknown.Without the return of the device, visibility and functionality is unknown.There is not yet enough information available to classify the health impact.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 part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.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: 8814267
• Report Number: 1020279-2019-02719
• Device Sequence Number: 2513946
• Product Code: JDQ
• UDI-Device Identifier: 03596010485724
• UDI-Public: 03596010485724
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 71340020
• Device Lot Number: 18ESM0888
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1