MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 -3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71369720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that one (1) mi trial femoral head 36mm -3 and one (1) mi trial femoral head 36mm + 0 have the inside broken off.In addition, two (2) easy plastic tray lids are cracked.As this was noticed upon field inspection, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the return product confirms multiple scratches burrs and deep gouges in the plastic on the outer and inner surface of the trial.Also the visual confirms one of the inner tabs is broken off, confirming the stated failure mode.The broken piece was not returned.The date of manufacture is unknown for this part.This device shows signs of excessive wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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: MI TRIAL FEM HEAD 36 -3
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12474687
• Report Number: 1020279-2021-06871
• Device Sequence Number: 19681171
• Product Code: HRY
• UDI-Device Identifier: 03596010559913
• UDI-Public: 03596010559913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 71369720
• Device Catalogue Number: 71369720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1