MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II STEMLESS TIB TR SZ 1 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED

Model Number 71430177

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that during a tka surgery a genesis ii stemless tib tr size 1 right was nailed to the tibia, then the 11mm drill was inserted into the hole to prepared for the fin punch.The drill bound in the hole and ripped the baseplate trial off and some bone pulled away from the tibia.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned trial confirms a piece of the trail broken off.The broken piece was not returned with the device.The device shows signs of normal wear and use.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.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 the risk management file revealed this failure mode was previously identified.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 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: GNS II STEMLESS TIB TR SZ 1 RT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11716180
• MDR Text Key: 246995614
• Report Number: 1020279-2021-03368
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010211545
• UDI-Public: 03596010211545
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71430177
• Device Catalogue Number: 71430177
• Device Lot Number: 15CM19998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention