MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 LT; PROSTH, KNEE, PAT/FEMTIB, SM-CNSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY

Catalog Number	71433346
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure, the housing reamer could not be removed from the femoral trial.The screws on a posterior stabilized reamer housing separated.Another narrow femoral trial size 6 was used to finish the procedure without delays.Patient was not harmed in any way.No other complications were reported.
Additional Manufacturer Narrative
Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The collet is stuck on the trial, rendering the device inoperable.The thumbscrews also disassembled from the collet.All pieces were returned.The device was manufactured in 2010 and shows signs of extensive use.A functional evaluation was attempted but the devices could not be separated.One of the collet retaining screws appears to be cross-threaded into the trial.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 do not have 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.Should 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 REAMTHRU CR TR SZ 6 LT
• Common Device Name: PROSTH, KNEE, PAT/FEMTIB, SM-CNSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10109101
• Report Number: 1020279-2020-01934
• Device Sequence Number: 16924686
• Product Code: MBH
• UDI-Device Identifier: 00885556032107
• UDI-Public: 885556032107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71433346
• Device Lot Number: 10HM02460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1