MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL IMPACTOR; PROSTHESIS, KNEE, FEMO, NON-CONS, CEMENTED, METAL/POLYMER

Model Number	71563450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the instrument broke.The device broke inside the patient and it is unknown if all the pieces were recovered.No delay was reported and it is unknown if there was a backup device available.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection was performed and confirmed that the impactor body has fractured.The device was manufactured in 2018.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 probable causes could be due to the heating and cooling associated with autoclaving or prolonged use.This failure mode has been previously identified.A design change has been implemented to reduce/eliminate this failure mode from recurrence.This device was manufactured prior to these corrective actions.

• Brand Name: FEMORAL IMPACTOR
• Common Device Name: PROSTHESIS, KNEE, FEMO, NON-CONS, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9799017
• Report Number: 1020279-2020-00811
• Device Sequence Number: 13599698
• Product Code: HSX
• UDI-Device Identifier: 03596010573292
• UDI-Public: 03596010573292
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 71563450
• Device Catalogue Number: 71563450
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR