MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	351-10-26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during impaction of the center peg hole, the surgeon recognized a severe form of sclerotic bone.While performing the impaction, the impactor tip of the center peg punch broke.When impacting the final tibial component, this issues again occurred and led to a breakage of the tibial radel impactor.There was a 5-15 mins surgical delay.No parts or pieces fell into the patient wound site.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: h3: the broken mobile bearing tibial radel impactor reported was likely the result of a stress riser introduced while impacting the tibial component into ¿a severe form of sclerotic bone,¿ which led to crack initiation, propagation, and ultimate fracture of the radel surface.The broken center peg punch was likely the result of both high impaction forces and the patient¿s hard bone, which led to crack initiation, propagation, and ultimate fracture of the peg punch tip.Section h11: the following sections have corrected information: h6: component code: 4722, shock absorber.

• Brand Name: VANTAGE
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gaiensville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14859398
• Report Number: 1038671-2022-00744
• Device Sequence Number: 20032038
• Product Code: HSN
• UDI-Device Identifier: 10885862290878
• UDI-Public: 10885862290878
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/28/2022

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: 351-10-26
• Device Catalogue Number: 351-10-26
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown