MAUDE Adverse Event Report: EXACTECH, INC. TRUL FEM IMPACTOR HEAD LOCKING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TRUL FEM IMPACTOR HEAD LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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 instrument has been broken while inserting the femoral component.There were no parts or pieces left in the patient.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
Section b5: additional information received indicates that only impactor handle was impacted.The femoral impactor was damaged during the impact.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the broken device reported was likely the result of the femoral impactor head being directly impacted during a previous surgical use, which may have imposed high loads to the threaded shaft and led to crack initiation and propagation of the threaded shaft.This prior potential misuse likely allowed for ultimate failure of the device when used during this surgery.The most probable root cause for the reported event "broken / non-functional" is associated with a partial or full-thickness crack in the device materials.

• Brand Name: TRUL FEM IMPACTOR HEAD LOCKING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 11848056
• Report Number: 1038671-2021-00241
• Device Sequence Number: 11693433
• Product Code: LXH
• 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): 11/12/2021

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: 149325008
• 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: 04/29/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 10/11/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 10/06/2021; 11/12/2021
• 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