MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71441144
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka, the locking mechanism of a genesis ii mis dcf align gde was loose and would not tighten properly.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode but could confirm that the device has nicks and scratches on it.The device shows signs of extensive use.A functional evaluation of the returned device confirms the stated failure mode.The locking mechanism on the device is worn, rendering the device inoperable.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.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.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.

• Brand Name: GII MIS DCF ALIGN GDE
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11918403
• Report Number: 1020279-2021-04933
• Device Sequence Number: 19627879
• Product Code: MBH
• UDI-Device Identifier: 03596010497161
• UDI-Public: 03596010497161
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/21/2021

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 Model Number: 71441144
• Device Catalogue Number: 71441144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1