MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AGC V/2 QUICK RELEASE DRILL BITS; INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that total knee arthroplasty was performed and during the procedure the quick-release drill fractured.All pieces were removed from the patient.No issues of the patient were reported.No additional information is available.

Manufacturer Narrative

(b)(4).Upon receipt of additional information it has been determined that this device did not cause and adverse event and is not reportable.  the initial report was submitted in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Upon receipt of additional information it has been determined that this device did not cause an adverse event and is not reportable.  the initial report was submitted in error and should be voided.

• Brand Name: AGC V/2 QUICK RELEASE DRILL BITS
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9289356
• MDR Text Key: 165378319
• Report Number: 0001825034-2019-05023
• Device Sequence Number: 1
• Product Code: HWT
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-467619
• Device Lot Number: 607164
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention