MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN 2.5MM HEX SCRWDRVR; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number 71434455

Device Problems Material Deformation (2976); Naturally Worn (2988)

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

Event Date 03/04/2021

Event Type  malfunction  

Event Description

It was reported that, during a knee revision, the small hex wrench for set screws of a legion revision is worn and broken.It was stripped when trying to tighten set screws.It is unknown is there was any delay or how the procedure was completed.

Manufacturer Narrative

G3, h2,h3 and h6: the device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

It was reported that, during a knee revision, the small hex wrench for set screws of a legion revision is worn and broken.It was stripped when trying to tighten set screws.Procedure was completed with the same device.There was no delay.

• Brand Name: LGN 2.5MM HEX SCRWDRVR
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11586751
• MDR Text Key: 242885368
• Report Number: 1020279-2021-02470
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010550200
• UDI-Public: 03596010550200
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 71434455
• Device Catalogue Number: 71434455
• Device Lot Number: 17EM14348
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention