MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FLEX-EXT SPACER 10MM; PROSTHESIS, KNEE, SEMI-CNSTRAIND,CMNTD, POLYMER/METAL/POLYMR

Model Number	74018610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the spacer broke while removal from patient.It is unknown if any piece was left inside the patient.A back up was available.
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 instrument broke outside the patient and nothing was left inside the patient, 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: JOURNEY FLEX-EXT SPACER 10MM
• Common Device Name: PROSTHESIS, KNEE, SEMI-CNSTRAIND,CMNTD, POLYMER/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9553402
• Report Number: 1020279-2020-00112
• Device Sequence Number: 14303642
• Product Code: JWH
• UDI-Device Identifier: 03596010557117
• UDI-Public: 03596010557117
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: No Information
• Device Model Number: 74018610
• Device Catalogue Number: 74018610
• Device Lot Number: 13CM13087
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1