MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DRILL BIT; BIT, DRILL

Device Problem Fracture (1260)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 2.2/2.7 mm soft tissue guide, cat#233500004, lot#516549.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 during a procedure the drill bit became lodged in the drill sleeve causing the bit to get so hot it discolored the outer sleeve of the drill bit and then it fractured.There was no foreign body retained and no harm to patient or surgeon.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 visual examination of the returned products noted the fractured drill bit stuck inside the guide.The complaint is confirmed.Item and lot numbers of the drill bit are not visible as only the tip is showing through the guide.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.The root cause of the reported issue is attributed to a design deficiency, resulting in the drill bit being stuck in the guide and fracturing during attempted removal.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 is available at the time of this report.

• Brand Name: UNKNOWN DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11011116
• MDR Text Key: 222024075
• Report Number: 0001825034-2020-04266
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1