MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRECOAT FEMORAL DRILL W/STOP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 00584301800

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

It was reported that during efip inspection process, was noticed that the precoat femoral drill w/stop is dull and gouged metal on shaft.There was no case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.The stated failure was confirmed through a visual inspection that the femoral drill is dull and has burrs from contact with mating device.This device shows significant signs of wear/usage.This device was manufactured in 2015.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: PRECOAT FEMORAL DRILL W/STOP
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10591587
• MDR Text Key: 208711647
• Report Number: 1020279-2020-04905
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885556621318
• UDI-Public: 00885556621318
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00584301800
• Device Catalogue Number: 00584301800
• Device Lot Number: 63194157
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1