MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71440190

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2020

Event Type  malfunction  

Event Description

It was reported that during tka procedure the gii femoral impactor chipped while being used inside the patient.The cracked piece was recovered with no harm to the patient.There was no delay and a s&n back up device was available to complete the procedure.No other complication 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

The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.According to clinical/medical investigation , this case reports the impactor chipped inside the patient while impacting.The broken piece was retrieved, and the procedure was completed using a backup device without patient injury or delay.No further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 not be issued for the device.

• Brand Name: GII FEMORAL IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10812157
• MDR Text Key: 215371304
• Report Number: 1020279-2020-06288
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214379
• UDI-Public: 03596010214379
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 05/08/2021

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: 71440190
• Device Catalogue Number: 71440190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention