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

Model Number	71340007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during procedure the acc 2.0mm cocr cable w/clamp was cut off when tensioner was applied.It had been shifted several times.Instruments inside the patient.It can not deny possibility of remaining in the body.The procedure was completed with a delay less than or equal to 30min with a smith-nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that the the accord cable with clamp was cut off when tensioner was applied, and that it had shifted several times.Per email correspondence, the broken piece was removed, but fine fragments may still be in the body.Post-op x-rays were requested, however it was unknown if any were obtained to confirm the presence of any fragments.The procedure was completed using a backup device with no patient injury and a minimal delay.No further clinical assessment is warranted.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but are not limited to, excessive forces applied or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ACC 2.0MM COCR CABLE W/CLAMP
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11593536
• Report Number: 1020279-2021-02567
• Device Sequence Number: 11664161
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71340007
• Device Catalogue Number: 71340007
• Device Lot Number: 20GSM0443
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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