MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.0X56MM DRILL MQC STE; BIT, DRILL

Catalog Number 231221200

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02737.

Event Description

It was reported that during a procedure two different drill bits broke.Two minute delay to change out drills.The tip of the drill bit was left in the patient's bone per the 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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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: 1.0X56MM DRILL MQC STE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10283826
• MDR Text Key: 199120496
• Report Number: 0001825034-2020-02738
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 231221200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1.0X56MM DRILL MQC STE CAT#231221200 LOT#NI; 1.0X56MM DRILL MQC STE CAT#231221200 LOT#NI
• Patient Outcome(s): Other
• Patient Age: 73 YR