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 02/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during tka surgery when placing the femoral implant, the impactor broke inside the patient while the surgeon used it to ensure the implant was set properly.The procedure was completed without delay using a smith and nephew back-up device.No other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirms impactor bumper has fractured into two pieces.Both pieces were returned with the device.The device shows signs of significant wear/use.A medical investigation was conducted and confirms per complaint details, the impactor broke during impaction.Per correspondence, ¿no pieces fell into the wound¿ and they were ¿all gathered outside of the patient¿.Reportedly, the procedure was completed using a backup s+n device without delay and no patient injury was reported.It was communicated that the requested medical documentation was not available.Patient impact beyond the use of the backup device would not be anticipated as the procedure was reportedly completed without patient harm, and/or surgical delay.Since no patient injury/harm or surgical delay was alleged, no further medical assessment is warranted at this time.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 any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 11546100
• MDR Text Key: 241567721
• Report Number: 1020279-2021-02292
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2012
• Device Model Number: 71440190
• Device Catalogue Number: 71440190
• Device Lot Number: 02GM06083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention