MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440194

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

It was reported that the tip of a genesis ii articular inserter/extractor have a crack.As this was noticed upon inspection, there was not patient involvement.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirms the tip is cracked.This device exhibits signs of significant use and wear.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.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII ARTICULAR INSERTER/EXTRACT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12408459
• MDR Text Key: 269405808
• Report Number: 1020279-2021-06674
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010214393
• UDI-Public: 03596010214393
• 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
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

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: 71440194
• Device Catalogue Number: 71440194
• Device Lot Number: 13HM05594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1