MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII LONG STEM EXTRACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while inside the patient, threads of the instrument broke.All pieces were retrieved and discarded by hospital staff.Procedure continued with a backup device from smith and nephew, with a delay of less than 30 minutes and without a delay.
Additional Manufacturer Narrative
Additional information: d4, h4.H3, h6: the associated device, used in treatment, was returned and evaluated.Visual inspection of the returned device confirms that the device is damaged, broken and has signs of wear and tear from use.The clinical/medical evaluation concluded that this complaint from the united states reports that a genesis ii long stem extractor broke during use.All pieces retrieved but it was discarded by hospital staff.The procedure continued with a backup device from smith and nephew, with a delay of less than 30 minutes and without a delay.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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.We consider this investigation closed.

• Brand Name: GII LONG STEM EXTRACTOR
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10652205
• Report Number: 1020279-2020-05260
• Device Sequence Number: 19514767
• Product Code: HRY
• UDI-Device Identifier: 03596010214348
• UDI-Public: 03596010214348
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71440186
• Device Catalogue Number: 71440186
• Device Lot Number: 12CM08796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention