MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LEGION INSTRUMENT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	UNKNOWN
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka procedure, drill was shedding metal shaving when placed through cutting block.No delay.Case completed with the same device after being cleaned.Metal shavings fell inside the patient, surgeon believes a potential infection could happen due to metal shavings.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.The clinical/medical team concluded, this complaint from the united states reports that during a tka the drill was ¿shedding metal shaving¿.The case was completed after ¿being cleaned¿.However, some metal shavings were not able to be removed.No delay was reported.The surgeon believes there is the potential for the metal shavings to cause an infection.The instrument is made of a surgical grade stainless steel and not intended for implantation.No intraoperative pictures or x-rays were provided with this report.It is unknown at this point if this will cause any adverse effect.The drill was not returned.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Impact to the patient cannot be determined at this time.The root cause of this event cannot be concluded, based on the limited information.The age of the tool or the method and technique used are unknown.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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: UNKNOWN LEGION INSTRUMENT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9557705
• Report Number: 1020279-2020-00138
• Device Sequence Number: 10627190
• Product Code: MDM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 18RM12113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1