MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71441353

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Event Description

It was reported that during tka the tip broke off upon case.No delay, injury or back up reported.

Manufacturer Narrative

The associated journey uni tibial impactor was returned and evaluated.A visual inspection of the returned device confirmed the failure mode as the plastic tip on the end of the impactor bumper has fractured off, the broken piece is not returned.The device was manufactured in 2008 and it exhibits signs of significant wear/usage.The crack is likely due to repeated impacts seen during impaction.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY UNI TIBIAL IMPACTOR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8205528
• MDR Text Key: 131706633
• Report Number: 1020279-2018-02949
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010588050
• UDI-Public: 03596010588050
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71441353
• Device Lot Number: 08DM05453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1