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

Model Number	TRUL FEM IMPACTOR HEAD LOCKING
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00372.
Event or Problem Description
As reported, the pin puller (cat# 02-029-90-4100) was used to remove the pins out of the tibia.The bone quality was very good and when the surgeon tried to remove the pin, the tip of the pin puller broke off.Furthermore, the fem impactor (02-029-19-1000) was broken on impaction when we were impacting the final femur implant on.One of the sides of the impactor broke off.The surgery was not affected by the breakage.We had backups and the case went very well.Patient was last known to be in stable condition following the event.The devices will be returned.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00372 and 1038671-2021-00373.
Additional Manufacturer Narrative
Section b5: additional information received indicates that there were no parts or pieces of the device that felled into the patient.(h3) the broken device reported was likely the result of the femoral impactor head being directly impacted during this surgery or a previous surgical use, 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 a partial or full-thickness crack in the device materials.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00372 and 1038671-2021-00373.

• Brand Name: TRUL FEM IMPACTOR HEAD LOCKING
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: 12287903
• Report Number: 1038671-2021-00373
• Device Sequence Number: 17061527
• Product Code: JWH
• UDI-Device Identifier: 10885862523587
• UDI-Public: 10885862523587
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 11/15/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/07/2021; 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown