MAUDE Adverse Event Report: EXACTECH, INC. 3 PEG PATELLA TRIAL 35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3 PEG PATELLA TRIAL 35MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use the patella peg has fractured on the trial.There were no pieces of parts fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Upon further investigation, information was reviewed, and it was noted that this case is a duplicate case; therefore, this case will be voided.The reported event of "patella peg has fractured on the trial.There were no pieces of parts fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event".Furthermore, the reported device malfunction did not cause or contribute to serious deterioration in state of health or death and is not likely to cause or contribute to serious deterioration in state of health or death if the malfunction were to recur.

• Brand Name: 3 PEG PATELLA TRIAL 35MM
• 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: 14823380
• Report Number: 1038671-2022-00715
• Device Sequence Number: 17296377
• Product Code: LXH
• UDI-Device Identifier: 10885862041760
• UDI-Public: 10885862041760
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/07/2022

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: 3 PEG PATELLA TRIAL 35MM
• Device Catalogue Number: 201-02-35
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 12/07/2022
• 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