MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 9MM X 38CM RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,PLYMR/METAL/PLYMR

Model Number	71640538
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision procedure at (b)(6) medical center, the meta-tan nail was found broken inside the patient.The nail was supposed to be explanted and replaced with a competitor product.The item broke at the distal end at the point of one of the screw holes.All pieces were recovered.

• Brand Name: META-TAN 9MM X 38CM RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,PLYMR/METAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9968593
• Report Number: 1020279-2020-01311
• Device Sequence Number: 2208854
• Product Code: JWH
• UDI-Device Identifier: 00885556339190
• UDI-Public: 00885556339190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092748
• 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): 05/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71640538
• Device Catalogue Number: 71640538
• Device Lot Number: 17DT86060
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention