MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 9MM; PRSTHSSKNEEPTLLOFMROTBLSMICNSTRIDCMNTDPLYMR/MTAL/PLYMR

Model Number	71420816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, stabilized posterior insert presented failures as it did not locked; good exposure of the tibial base was performed, it was checked that it would be free of tissue and the insert will slide, which did not lock; several attempts were used which were failed.It was decided to pass another stabilized posterior insert 3 4 9mm.Delay of 30 minutes 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 backup device from smith+nephew and same size was used to complete the procedure, 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: GII PS INSERT SZ 3-4 9MM
• Common Device Name: PRSTHSSKNEEPTLLOFMROTBLSMICNSTRIDCMNTDPLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9586037
• Report Number: 1020279-2020-00245
• Device Sequence Number: 3674551
• Product Code: JWH
• UDI-Device Identifier: 03596010209573
• UDI-Public: 03596010209573
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 71420816
• Device Catalogue Number: 71420816
• Device Lot Number: J1905866
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1