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

Catalog Number 351-90-24

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that the talar trial screw broke intraoperatively.The head of the talus temporary screw for a tar broke off while trying to remove.Nothing seemed out of the ordinary while removing.The head snapped off and surgeon was not going to remove it since it was not an issue or posed any harm to the patient.The shaft of the screw is still in the talus.

Manufacturer Narrative

H10: (d4) catalog number: 351-90-24, serial number: (b)(6) , expiration date: 06-mar-2028, unique identifier (udi) #: (b)(4).(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 and x-ray images were not provided.(h4) device manufacture date: 08-mar-2019.(h6) evaluation codes: 3165, 1069.Section h11: the following sections have corrected information: (d2) common device name: talar trial screw pouch.(h1) type of reportable event: serious injury.(h5) labeled for single use?: yes.

• Brand Name: VANTAGE
• Type of Device: TALAR TRIAL SCREW POUCH
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9106325
• MDR Text Key: 189074724
• Report Number: 1038671-2019-00466
• Device Sequence Number: 1
• Product Code: HSN
• 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: 08/20/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 351-90-24
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention