MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SWIVEL CLAMP; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71934656
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after a patient underwent a process to correct the axis, the clamp placed and protected with wires did not work.The patient went through a medical intervention so the doctor made a new secure construct using ilizarov parts.The axis correction will be completed in 2-3 months.
Additional Manufacturer Narrative
H6: the device, intended for use in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical / medical investigation concluded that, based on the limited information provided and without the return of the device the root cause of the events could not be determined.The impact to the patient beyond the reported cannot be concluded.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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 not limited to procedural/user variance or surgical complication.Based on this investigation, the need for corrective action is not indicated.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: SWIVEL CLAMP
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11197012
• Report Number: 1020279-2021-00485
• Device Sequence Number: 666736
• Product Code: KTT
• UDI-Device Identifier: 00885556235843
• UDI-Public: 00885556235843
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K090926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 71934656
• Device Catalogue Number: 71934656
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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; Required Intervention
• Patient Age: 15 YR