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

Model Number 71441353

Device Problems Break (1069); Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Event Description

It was reported that after a ukr, a jrny uni tibial impactor, had a reprocessing problem and it was not reprocessed by the sterile services, after it was used in a surgery performed in (b)(6), the device was broken and cracked.Surgery was cancelled as consequence of this problem.Patient was not injured.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned journey uni tibial impactor confirms the plastic bumper has a piece missing.This piece was not returned with the device.Also the bumper is cracked.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.D8 and d9: device returned.G2: report source update.G4: add 510k code.

• 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 rd.; memphis TN 38116
• MDR Report Key: 12250814
• MDR Text Key: 264271987
• Report Number: 1020279-2021-06132
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441353
• Device Catalogue Number: 71441353
• Device Lot Number: 18HM01767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1