MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SHORTQUICK-RELEASE DRILL HUCK; BIT, DRILL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that, when inserting the thread pins into the humeral cutting block, the end of the pin fractured off in the pin driver.This caused the pin driver to be unable to grasp the pin.The pin driver fractured during surgery but there was no harm to the patient.There is no additional information at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was reported in error.The initial report was submitted in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined that this device was reported in error.The initial report was submitted in error and should be voided.

• Brand Name: VNGD SHORTQUICK-RELEASE DRILL HUCK
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9151528
• MDR Text Key: 195109551
• Report Number: 0001825034-2019-04415
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-486259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1