MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; GAP CHECK TOOL SZ 3-4

Catalog Number	351-10-08
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgical use the ankle sizer was put into patient and snapped in half.Surgeon was able to remove the sizer and continue on with the case.The patient was not injured during this case.There was no surgical delay.Patient was last known to be in stable condition following the event.This incident did not effect the outcome of the surgery nor have any adverse effects on the patient health.(b)(4).
Additional Manufacturer Narrative
The broken instrument reported may have been the result of applying a bending moment to the device or impacting the device during resection gap verification, which led to ultimate fracture of the fixed bearing gap check tool.

• Brand Name: VANTAGE
• Common Device Name: GAP CHECK TOOL SZ 3-4
• 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 ; 3523771140
• MDR Report Key: 12891627
• Report Number: 1038671-2021-00642
• Device Sequence Number: 19924503
• Product Code: LXH
• UDI-Device Identifier: 10885862525673
• UDI-Public: 10885862525673
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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 Catalogue Number: 351-10-08
• Device Lot Number: 400117007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown