MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 9; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012419

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure it was used the strike plate cover, the journey dcf ap fem cut blk 9 was impacted and the capture snapped off.This happened during use inside the patient.The patient is fine.Nothing was retained.No delay.No back up applicable for this case.No other injuries or complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirms the strike plate cover broke off.The broken piece was returned with the device.The device was manufactured in 2017.The device exhibits signs of significant wear and usage.A medical investigation was conducted and this case reports the strike plate cover was impacted, and the capture snapped off during use inside the patient.All pieces of the device were returned, therefore all pieces were removed from the patient.Per complaint details, there was no backup device available, and there were no patient injuries or surgical delay.Since no harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaints 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.A review of risk management files found that the reported failure was documented appropriately.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: JOURNEY DCF AP FEM CUT BLK 9
• 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: 10787210
• MDR Text Key: 214624009
• Report Number: 1020279-2020-06155
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556714
• UDI-Public: 03596010556714
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012419
• Device Catalogue Number: 74012419
• Device Lot Number: 17EM07083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention