MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CMENTD, METAL/POLYMR

Model Number 71440190

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

It was reported that a piece of the impacting surface chipped off during impaction.The device broke inside of the patient.Surgery was completed with the same device.No backup device was available, but surgery was completed with the same device and a delay no greater than 30 min was reported.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A small section of the boss on the plastic bumper fractured off the device and was not returned.The device was manufactured in 2017 and shows signs of extensive wear/usage.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.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

Event Description

It was reported that a piece of the impacting surface chipped off during impaction.The device broke inside of the patient.No backup device was available, but surgery was completed with the same device and a delay no greater than 30 min was reported.

• Brand Name: GII FEMORAL IMPACTOR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CMENTD, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9805741
• MDR Text Key: 182563928
• Report Number: 1020279-2020-00816
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010214379
• UDI-Public: 03596010214379
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440190
• Device Catalogue Number: 71440190
• Device Lot Number: 17DM09118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR