MAUDE Adverse Event Report: EXACTECH, INC. TRUL FEM TRIAL EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TRUL FEM TRIAL EXTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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 surgeon went to remove the femoral trial from the patient's femur using the femoral slap hammer attachment.After the second slap to try to remove the femur trial the instrument broke.The surgeon tried to use it after it had broken, and it would not remove the femur from the bone.The surgeon used an osteotome to remove the trail.No pieces were left in the patient.The slap hammer attachment tip broke during use.Patient was last known to be in stable condition following the event.The instrument is being sent back to exactech and a new one has been ordered for replacement.
Additional Manufacturer Narrative
Upon further review and due to the investigation findings, this complaint was determined to be not reportable.The reported device malfunction did not cause or contribute to a serious deterioration in state of health or death and is not likely to cause or contribute to a serious deterioration in state of health or death if the malfunction were to recur.¿.

• Brand Name: TRUL FEM TRIAL EXTRACTOR
• 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: 12636698
• Report Number: 1038671-2021-00535
• Device Sequence Number: 16986676
• Product Code: LXH
• UDI-Device Identifier: 10885862584175
• UDI-Public: 10885862584175
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/29/2021

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 TRIAL EXTRACTOR
• Device Catalogue Number: 02-029-19-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 105 KG