MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTH, KNEE, PAT/FEM, SEMI-CONS, UNCEMEN, POROUS, COATED, POLY/METAL/POLY

Model Number 74012415

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  Injury  

Event Description

It was reported that the surgeon tried to remove the block with the slap hammer he couldn't because did not slide over the center dial, as the block was not compatible with the slap hammer.He used a curved osteotome to lift off the cutting block.There was no delay in the case.There were no backup devices of the same size available for the case at the hospital.The procedure finished with the same device.No harm was done to the patient.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2008 and shows signs of extensive wear/usage.The functional evaluation could not confirm the stated failure mode.The device functioned as intended with a mating slap hammer.The medical investigation concluded that there was no delay in the case and no harm to the patient was reported.No clinical/medical documentation was provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.All efforts to obtain additional information regarding this complaint did not provide any results.If additional supporting medical documents are received, this complaint will be reassessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 5
• Type of Device: PROSTH, KNEE, PAT/FEM, SEMI-CONS, UNCEMEN, POROUS, COATED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9992905
• MDR Text Key: 188738584
• Report Number: 1020279-2020-01370
• Device Sequence Number: 1
• Product Code: MBH
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74012415
• Device Catalogue Number: 74012415
• Device Lot Number: 08LM08261
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention