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

Catalog Number 71441353

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

It was reported that the journey uni tibial impactor was found to be broken during a routine efip inspection.There were no reported problems from any cases.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned journey uni tibial impactor confirms the plastic bumper is missing from the device.This piece was not returned with the device.Also the end of the device is damaged.This instrument was manufactured in 2007.The device shows signs of significant use and wear.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: JRNY UNI 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
• MDR Report Key: 10469308
• MDR Text Key: 204856010
• Report Number: 1020279-2020-04291
• Device Sequence Number: 1
• Product Code: HSX
• 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
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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: 07FM13436
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1