MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF FEM ALIGN GDE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71440850
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bolt/screw is missing from the gii post ref fem align gde.This could happened during sterilization process.Malfunction was found during set up/inspection in tka procedure.There was no delay.A s&n back up device was available to complete the procedure.No injuries reported at this time.
Additional Manufacturer Narrative
Component code, guide.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could confirm the stated failure mode.The screw on the device is missing, rendering the device inoperable.The device shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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 POST REF FEM ALIGN GDE
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10979958
• Report Number: 1020279-2020-07311
• Device Sequence Number: 10899168
• Product Code: JDG
• UDI-Device Identifier: 03596010390394
• UDI-Public: 03596010390394
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2021

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: 71440850
• Device Catalogue Number: 71440850
• Device Lot Number: 15LCT0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 06/04/2021; 06/16/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 06/07/2021; 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1