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

Model Number	00584301800
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10591587
• Report Number: 1020279-2020-04905
• Device Sequence Number: 2410065
• Product Code: LXH
• UDI-Device Identifier: 00885556621318
• UDI-Public: 00885556621318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 00584301800
• Device Catalogue Number: 00584301800
• Device Lot Number: 63194157
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1