MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PATELLAR REAMER SHAFT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440324

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that, during surgery, the ring around the gold button of the gii patellar reamer shaft was no longer attached.Device outside the patient.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection of the returned gii patellar reamer shaft confirms the ring is missing from the device.The piece was not returned with the device.The instrument exhibits significant signs of wear/usage.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints 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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are prior actions related to this device and failure mode.The had a design change for the shaft component.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 future complaints and investigate as necessary.

• Brand Name: GII PATELLAR REAMER SHAFT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13090815
• MDR Text Key: 283680171
• Report Number: 1020279-2021-08869
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010214997
• UDI-Public: 03596010214997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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 Expiration Date: 11/01/2015
• Device Model Number: 71440324
• Device Catalogue Number: 71440324
• Device Lot Number: 05HM14462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1