MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; PUNCH LINER-FB-SZ 2-8MM

Catalog Number	351-15-22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported, during surgical use, the surgeon used the size 2 8mm poly to set alignment with the talus and tibia trials in the 74 year old male patient.Surgeon pulled the poly out with a ronjour and the poly broke.All parts and pieces that fall into patient wound site were removed by the surgeon.The piece of the poly was removed.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
Lot number: 326638013.(h3) the broken punch liner reported may have been due to improperly attaching the punch liner to the tibial punch guide, which positioned the extraction feature inside the wound site.The absence of the extraction feature on the outside of the wound site likely resulted in the need to use a surgical tool, such as a ronjour, to remove from the tibial punch guide and resulted in the observed damage.

• Brand Name: VANTAGE
• Common Device Name: PUNCH LINER-FB-SZ 2-8MM
• 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: 13939693
• Report Number: 1038671-2022-00308
• Device Sequence Number: 17341366
• Product Code: LXH
• UDI-Device Identifier: 10885862291417
• UDI-Public: 10885862291417
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 351-15-22
• Device Lot Number: 326638013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male