MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; ANKLE TIBIAL CENTER PUNCH

Model Number ANKLE TIBIAL CENTER PUNCH

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Device pending evaluation.

Event Description

As reported, during the punch guide broke during the impaction.No parts or pieces fell into the wound site.There was no impact to the patient.Device will be returned.

Manufacturer Narrative

(h3) the broken center peg punch reported may have been the result of both high impaction forces and the patient¿s hard bone.However, this cannot be confirmed as the device was not available for evaluation.

• Brand Name: VANTAGE
• Type of Device: ANKLE TIBIAL CENTER PUNCH
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10425637
• MDR Text Key: 203523354
• Report Number: 1038671-2020-00498
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862290878
• UDI-Public: 10885862290878
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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
• Device Operator: Health Professional
• Device Model Number: ANKLE TIBIAL CENTER PUNCH
• Device Catalogue Number: 351-10-26
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention