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

Catalog Number 71340007

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  malfunction  

Event 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.

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: ACC 2.0MM COCR CABLE W/CLAMP
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8765818
• MDR Text Key: 150256326
• Report Number: 1020279-2019-02622
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: K031162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 71340007
• Device Lot Number: 18MSM0312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/06/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1