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 Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Event Description

It was reported that during set up the surgeon states that the threads on one of the thumb screws stripped and broke.There was no delay nor injury reported.A s&n backup device was available to finish the surgery.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries.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 or product information, our investigation could not proceed.Should the device or 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 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: 10298859
• MDR Text Key: 199635130
• Report Number: 1020279-2020-03349
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• 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: UNKNOWN/UNREADABLE
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1