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

Model Number 71441353

Device Problem Break (1069)

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

Event Date 04/20/2021

Event Type  Injury  

Event Description

It was reported that during a tka, the plastic a jrny uni tibial impactor broke while impacting the tibia inside the patient.All pieces were removed from patient.There was no significant delay and the procedure was finished using the same device.Surgery was completed without further incident.Patient was not harmed.

Manufacturer Narrative

The device used in treatment was returned and evaluated.Visual inspection of the impactor confirms that the device is broken and displays heavy signs of damage.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history revealed prior complaints for the listed part.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.A review of risk management file found that the reported failure was documented appropriately.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.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 rd.; memphis TN 38116
• MDR Report Key: 11814333
• MDR Text Key: 250284471
• Report Number: 1020279-2021-04113
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010588050
• UDI-Public: 03596010588050
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441353
• Device Catalogue Number: 71441353
• Device Lot Number: 15CM10594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention