MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REPL BIT FOR TORQUE WRENCH; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71565657

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2020

Event Type  Injury  

Event Description

It was reported that during tka surgery, was noticed that the repl bit for torque wrench is damaged and couldn¿t tighten the screw.The procedure was finished with a change in surgical technique, using a non torque 3.5 hex was used to tighten screw.There was no surgical delay and no injury to the patient.

Manufacturer Narrative

H6: 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 during a tka surgery, the hex bit for the torque wrench was damaged.Per complaint details, there was a change in surgical technique, and a non-torque hex was used to complete the procedure.There was no patient injury or delay reported.No further clinical assessment is warranted.A complaint history review found related failures for the listed device; 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of 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.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: REPL BIT FOR TORQUE WRENCH
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10794881
• MDR Text Key: 214988890
• Report Number: 1020279-2020-06227
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010412003
• UDI-Public: 03596010412003
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71565657
• Device Catalogue Number: 71565657
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention