MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN NARROW REAM THRU TRL 6N RT; PROSTHESISKNEPATELOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER

Model Number	71434156
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure it was noticed that the device had a crack.This did not affect the surgery but a replacement will be needed, no pieces were left in patient.No delay and no injury reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that device did not break, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LGN NARROW REAM THRU TRL 6N RT
• Common Device Name: PROSTHESISKNEPATELOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9753369
• Report Number: 1020279-2020-00708
• Device Sequence Number: 16797168
• Product Code: JWH
• UDI-Device Identifier: 00885556234655
• UDI-Public: 00885556234655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 71434156
• Device Catalogue Number: 71434156
• Device Lot Number: 13DPG0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1