MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PROSTHE,KNEE,FEMOROTI,SEMICONSTRAIN,CEMEN,MET/POLY

Model Number 71440366

Device Problem Break (1069)

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

Event Date 10/12/2020

Event Type  malfunction  

Event Description

It was reported that, during use, outside the patient, genesis ii universal extractor sheared in half during procedure.The procedure finished with a smith and nephew backup device.No surgical delay.Patient injuries were not reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history did not reveal additional complaints for the listed batch.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation 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 UNIVERSAL EXTRACTOR
• Type of Device: PROSTHE,KNEE,FEMOROTI,SEMICONSTRAIN,CEMEN,MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10797022
• MDR Text Key: 215003092
• Report Number: 1020279-2020-06257
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010215192
• UDI-Public: 03596010215192
• 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: 04/26/2021

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: 71440366
• Device Catalogue Number: 71440366
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1