MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY LOCKING TIBIAL IMPACTOR; PRSTHSS, KN, FMRTBL, NN-CNSTRND, CMNTD, MTL/PLYMR

Catalog Number 71935414

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

It was reported that during procedure and outside of the patient the screw on back of the journey locking tibial impactor came completely out and does not go back in.No injuries or delays reported.A s+n backup device was available.

• Brand Name: JOURNEY LOCKING TIBIAL IMPACTOR
• Type of Device: PRSTHSS, KN, FMRTBL, NN-CNSTRND, CMNTD, MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10248687
• MDR Text Key: 198076565
• Report Number: 1020279-2020-03007
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 71935414
• Device Lot Number: 19DM19400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1