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

Device Problem Device Slipped (1584)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that during surgery, the surgical drill "skidded to the left and caught in soft tissue".As a result of the skid, the patient's carotid artery was cut causing a large amount of blood to gush out.The surgery for the anterior cervical decompression and instrumented fusion was cancelled.

Event Description

It was reported that during surgery, the surgical drill "skidded to the left and caught in soft tissue".As a result of the skid, the patient's carotid artery was cut causing a large amount of blood to gush out.The surgery for the anterior cervical decompression and instrumented fusion was cancelled.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: UNKNOWN SURGICAL DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10928178
• MDR Text Key: 218958480
• Report Number: 3012447612-2020-00667
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other