MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRN BCS II BOX PREP GD SZ6-8; PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Model Number	74012576
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery an employee of (b)(6) hospital in the central sterilization department injured themselves due to a burr found on the journey ii bcs box prep guide size 6-8.The device was stuck in employee´s finger by a metal shaving sticking off of the instrument.
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 the event didn´t require medical intervention, 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: JRN BCS II BOX PREP GD SZ6-8
• Common Device Name: PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9664321
• Report Number: 1020279-2020-00462
• Device Sequence Number: 19694285
• Product Code: JWH
• UDI-Device Identifier: 00885556001042
• UDI-Public: 00885556001042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74012576
• Device Catalogue Number: 74012576
• Device Lot Number: 18KM00476
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/11/2020
• 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: Required Intervention