MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC ALIGN GUIDE RIGHT; PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR

Catalog Number	71441257
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka the nails of the items are open and have bone in them.No back-up 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 there was no malfunction and device is working as intended, 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 SPC ALIGN GUIDE RIGHT
• Common Device Name: PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8163237
• Report Number: 1020279-2018-02791
• Device Sequence Number: 2203517
• Product Code: MBH
• UDI-Device Identifier: 00885556034262
• UDI-Public: 00885556034262
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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): 03/26/2019

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 Catalogue Number: 71441257
• Device Lot Number: 09JM00576
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1