MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC P/S HOUS COLLET S 3-8; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440001

Device Problem Mechanical Problem (1384)

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

Event Date 07/14/2020

Event Type  malfunction  

Event Description

It was reported that during tka procedure the lockable housing collet would not screw in completely causing the housing not to lock in proper position.No delay or harm to the patient reported.It is unknown how the procedure was finished.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirmed the spring is damaged on the gii spc p/s hous collet s 3-8, which would cause the device not to function as intended.The device shows significant signs of wear/usage.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.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.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 SPC P/S HOUS COLLET S 3-8
• 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: 10379276
• MDR Text Key: 202035565
• Report Number: 1020279-2020-03772
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556033401
• UDI-Public: 00885556033401
• 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: 05/02/2021

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: 71440001
• Device Catalogue Number: 71440001
• Device Lot Number: 11CM016125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 05/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1