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

Model Number	71340020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery following a thr (the manufacturer is unknown since the devices are implanted 10 years ago), a binding cable of a accord 2.0mm cobalt chrome cable suddenly broke during the operation, which frightened the surgeon and questioned the product quality.There was a delay of 30 minutes or less and the procedure was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device confirmed the stated failure mode.One side of the cable was broken, rendering the device inoperable.The rest of the broken device was not returned.A review of complaint history did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.The anticipated risk level is still adequate.Some potential probable causes for this event could include but not limited to surgical technique or implant failure.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: ACCORD 2.0MM COCR CABLE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12806659
• Report Number: 1020279-2021-08126
• Device Sequence Number: 5511565
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71340020
• Device Catalogue Number: 71340020
• Device Lot Number: 18LSM0890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown