MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS REAMTHRU FEM TRIAL LEFT SIZE 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number E001300907

Device Problem Mechanical Jam (2983)

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

Event Date 05/24/2021

Event Type  malfunction  

Event Description

It was reported that, during a tka, using ream through femoral trials.While reaming the ps box, the collet screw jammed in the femoral trial and could not be removed.This means the surgeon could not trial again as the collet was still attached to the femoral trial.It is unknown how surgery was completed.Surgery was less than or equal to 30mins delayed.Patient was not harmed.

Event Description

It was reported that, during a tka, using ream through femoral trials.While reaming the ps box, the collet screw jammed in the femoral trial and could not be removed.This means the surgeon could not trial again as the collet was still attached to the femoral trial.The procedure was completed by not trialling, going straight to the definitive femoral component.All the cuts had been performed.Surgery was less than or equal to 30mins delayed.Patient was not harmed.

Manufacturer Narrative

G3, h2,h3 and h6: 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.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, 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.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned gii ps reamthru fem trial left size 6 confirms the gii spc p/s hous collet s 3-8 is stuck to the device.The device exhibits signs of extensive use and wear.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.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.D1, d4, h3, h6, h10.

• Brand Name: GII PS REAMTHRU FEM TRIAL LEFT SIZE 6
• 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: 11942244
• MDR Text Key: 254369535
• Report Number: 1020279-2021-05006
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E001300907
• Device Lot Number: 030513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1