MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE SIZE 5 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	00584202509
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, articular surface size 5 8mm broke while inside the patient.No pieces were left inside the patient.It is unknown how was the procedure concluded.No delay occurred due to this event and patient was not harmed beyond the described event.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned instrument confirms the stated failure mode.The articular surface provisional has fractured into two pieces.Both pieces were returned for evaluation.This instrument exhibits signs of significant use and wear.The articular provisional was manufactured in 2016.A medical investigation was conducted and confirms this case reports that a size 5/8mm zuk insert broke during use.The surgeon then placed a size 5/9mm zuk insert, which snapped in half when he extended the knee.The insert was left in place until the cement cured, and then the 2 pieces were removed.Per email correspondence, there were no pieces left inside the patient, and the procedure was completed without delay.Therefore, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 the risk management file revealed this failure mode was previously identified.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ARTICULAR SURFACE SIZE 5 9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11305579
• Report Number: 1020279-2021-01090
• Device Sequence Number: 14295676
• Product Code: HSX
• UDI-Device Identifier: 00885556620229
• UDI-Public: 00885556620229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00584202509
• Device Catalogue Number: 00584202509
• Device Lot Number: 63254972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention