MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 5 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	00584102508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our reference number: (b)(4).
Event or Problem Description
It was reported that, during tka surgery the zuk sz.5 8mm zuk poly trial was placed in the patient for sizing and broke in half inside.The procedure was completed without delay using a smith and nephew back-up device.No other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms the trial has broken into two pieces.Both pieces were returned.The device shows significant signs of wear/ usage.This instrument was manufactured in 2016.A medical investigation conducted and confirms this case reports the trial insert broke in half while being placed for sizing.A photo of the broken device confirms both pieces were retrieved.Per complaint details, there was no patient injury or delay reported and the procedure was completed using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted at this time.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 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.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 5 8MM
• 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: 11325744
• Report Number: 1020279-2021-01185
• Device Sequence Number: 14484568
• Product Code: HSX
• UDI-Device Identifier: 00885556619568
• UDI-Public: 00885556619568
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/15/2021

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: 00584102508
• Device Catalogue Number: 00584102508
• Device Lot Number: 63313529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/15/2021
• 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