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

Model Number 71934656

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during a replacement of "standard" clamp to swivel clamp surgery, the clamp of the modular rail system could not be fixed in the desired position, it did not lock.Then, a change in surgical technique was reported since the clamp was fixed during the procedure by using wires.It is unknown if there was a surgical delay.Procedure concluded with the same device.No other complications were reported at this time.

Manufacturer Narrative

H3, 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 review of 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 not limited to user error or procedural variance.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
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11056346
• MDR Text Key: 223162024
• Report Number: 1020279-2020-07694
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00885556235843
• UDI-Public: 00885556235843
• Combination Product (y/n): N
• PMA/PMN Number: K090926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71934656
• Device Catalogue Number: 71934656
• Device Lot Number: 19AM13672
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1