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 01/25/2018

Event Type  Injury  

Event Description

It was reported during a nail fixation surgery that the cable suddenly broke as it became tense.This caused a 40-min delay.

Manufacturer Narrative

The associated complaint device was returned and evaluated.It was reported that a cable broke during tensioning, which resulted in a procedural delay of 40 minutes, and blood loss.The procedure was completed using a back-up device.A visual inspection of the returned accord 2.0mm cocr cable with clamp confirms the stated failure.The cable is dismantled into two pieces near the beaded end.No patient injury was sustained as a result of this device related incident and/or reported blood loss.No further medical assessment is warranted based on the information provided.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If new information is received in the future, this complaint can be re-opened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7243062
• MDR Text Key: 99066961
• Report Number: 1020279-2018-00120
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• 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: 17FSM0022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• 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): Other
• Patient Age: 75 YR