MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM IMPL IMPACTOR; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number OR74012831

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Event Description

It was reported that the screw sheared off during surgery.No piece was left in the patient.No delay reported.A backup device was available.

Manufacturer Narrative

The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURNEY FEM IMPL IMPACTOR
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8787664
• MDR Text Key: 150970011
• Report Number: 1020279-2019-02668
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010556905
• UDI-Public: 03596010556905
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OR74012831
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1