MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012415

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2020

Event Type  Injury  

Event Description

It was reported that during surgery, the journey dcf ap fem cut blk 5 that was assembled with the journey ap cut block impactor (74012421) broke after impaction by hammer.The pin and the broken piece dropped inside the patient.The broken pieces were retrieved.After the operation, the doctor confirmed there was no left of the broken component with the x-ray.No delay added to the case.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken , damaged and has signs of wear and tear from use.The device was manufactured in 2018.According to clinical/medical investigation, this case reports the femoral cutting block broke after impaction by a hammer.The pin and the broken piece dropped inside the patient, and was retrieved, and was confirmed by x-ray.Per email communication, the requested x-ray and surgical report is not available.However, supporting photos confirm the broken pieces were retrieved.There was no patient injury or surgical delay reported.Since no patient harm is alleged, no further clinical assessment is warranted.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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.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.Credit will be issued for the device.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 5
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10871325
• MDR Text Key: 217291060
• Report Number: 1020279-2020-06577
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556677
• UDI-Public: 03596010556677
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012415
• Device Catalogue Number: 74012415
• Device Lot Number: 18KM25954
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74012421.
• Patient Outcome(s): Required Intervention