MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD DUAL ENDED HEX DRIVER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71360046

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

Internal reference: case (b)(4).

Event Description

It was reported that, during a revision surgery, the surgeon was using an accord cabling set.The surgeon asked for 2 cables to be opened, immediately following the removal of the femoral stem.Once adequate tension was achieved, the cables needed to be locked off by tightening a screw using a torque limiting driver.The nurse was instructed to put the accord dual ended hex driver on the torque driver handle.Surgeon tried tightening the screw until the audible click of the torque limiting driver, however, the accord dual ended hex driver tip was so badly stripped that he was not able to tighten the screw to lock the tension of the cable.The set usually contains two (2) drivers, both of which were not usable.As a result, he was unable to use the cables and surgery was completed, after a significant delay, using a competitor device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed part number, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: ACCORD DUAL ENDED HEX DRIVER
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 16993427
• MDR Text Key: 315853862
• Report Number: 1020279-2023-01122
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010611543
• UDI-Public: 03596010611543
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71360046
• Device Catalogue Number: 71360046
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1