MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TALAR TRIAL SCREW

Catalog Number	351-90-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during an ankle procedure on a (b)(6) y/o female patient, a screw broke when trying to pull it out with the screwdriver.When the surgeon tried to pull out the screw (351-90-04), which was fixing the right talar trial (351-04-01) in place, with the screw driver (351-93-01 + 351-93-02), the screw broke.The force applied was not higher than usual.The surgeon removed the lower part of the screw, which was in the bone of the patient, was removed with a small pair of pliers during which there was a 5-15 minute delay of the procedure.There was no negative effect to the patient.
Additional Manufacturer Narrative
Section h10: (h3) the broken talar trial screw reported may have been the result of applying a bending moment while removing the screw from the talus, allowing it to fracture.However, this cannot be confirmed as the device was not returned for evaluation.
Additional Manufacturer Narrative
Section h11: *the following sections have corrected information: (h3) the broken talar trial screw reported was likely the result of applying a bending moment to the screw while removing the screw from the talus, which led to ultimate fracture.(h6) type of investigation: 10 (testing of actual/suspected device), 4109 (historical data analysis).Investigation findings: 3252 (fracture problem).Investigation conclusion: 61 (unintended use error caused or contributed to event).

• Brand Name: VANTAGE
• Common Device Name: TALAR TRIAL SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson kate jacobson ; 3523771140
• MDR Report Key: 11938460
• Report Number: 1038671-2021-00278
• Device Sequence Number: 4066214
• Product Code: HSN
• UDI-Device Identifier: 10885862301505
• UDI-Public: 10885862301505
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: UNK
• 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): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 351-90-04
• Device Lot Number: 45124001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 02/10/2022; 02/10/2022
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 03/01/2022; 07/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female