MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AGC ACCU-LINE(R) QUICK RELEASE DRILL BITS 1/8IN.; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as a part of the device remained implanted in the patient and the other portion was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Insufficient information.

Event Description

It was reported that during knee revision arthroplasty of competitor devices, the drill bit fractured within the patient's knee.The surgeon was unable to remove the drill bit from the lateral condyle, and decided to leave it in the patient.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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

No further event information available at the time of this report.

• Brand Name: AGC ACCU-LINE(R) QUICK RELEASE DRILL BITS 1/8IN.
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10855503
• MDR Text Key: 216913236
• Report Number: 0001825034-2020-04110
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other