MAUDE Adverse Event Report: EXACTECH, INC. TRUL FEM IMPACTOR HEAD LOCKING; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRUL FEM IMPACTOR HEAD LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the doctor found that femoral impactor was broken after he completed surgery on a female patient.There was no delay in surgery as it worked well during the surgery.It was noted that the doctor seemed to not put strong pressure on the instrument when impacting the implant.The broken instrument was noted after closing the patient.It was reported there were no parts left in the patient and there was no delay to surgery.The patient was last known to be in stable condition following the event.The device is to be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g3, g7, h2, h3 and h6 have been updated accordingly.Section b5: additional information received indicates that during operation, the femoral impactor was broken.But the debris and product were already removed from patient.The femur part of knee was impacted.The femoral impactor impacted itself.There was no impact for handle.Only head of femoral impactor was impacted.(h3) the evaluation noted that revision reported was likely the result of the surgeon not using an impactor handle and impacting the femoral impactor head directly, which may have imposed high loads to the threaded shaft and led to ultimate fracture.However, this cannot be confirmed as the device was not returned for evaluation.The most probable root cause associated with the reported event of "broken / non-functional" is associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.Section d9: device available for evaluation.
Additional Manufacturer Narrative
(h3) the broken device reported was likely the result of the surgeon not using an impactor handle and impacting the femoral impactor head directly, which may have imposed high loads to the threaded shaft and led to crack initiation, propagation, and ultimate fracture of the threaded shaft.The most probable root cause associated with the reported event of "broken / non-functional" is associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.

• Brand Name: TRUL FEM IMPACTOR HEAD LOCKING
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11193280
• Report Number: 1038671-2021-00010
• Device Sequence Number: 17113383
• Product Code: JWH
• UDI-Device Identifier: 10885862523587
• UDI-Public: 10885862523587
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

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: TRUL FEM IMPACTOR HEAD LOCKING
• Device Catalogue Number: 02-029-19-1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 09/13/2021; 11/15/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 10/04/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female