MAUDE Adverse Event Report: BIOMET 3I TAPERED NAVIGATOR® CERTAIN® SURGICAL KIT; DRILL

Catalog Number SGTIKIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sinus Perforation (2277)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Zimmerbiomet complaint number: (b)(4).Patient identifier unknown.Age and date of birth: unknown.Patient sex :unknown.Weight: unknown.Lot number: unknown.First/given name and email address unknown / not provided pma/510(k) number unknown.Device will not be returned to the "manuf".

Event Description

It was reported that an unknown drill from a sgtikit perforated the patient's maxillary sinus cavity.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The tapered navigator® certain® surgical kit (sgtikit) was not returned.Since product has not been returned, visual/functional inspection could not be performed.Pictures or x-ray images were not provided.No device lot number was provided so a device history record review and a complaint history review could not be performed.Manufacturer reported to sale manager that the surgical protocol was altered for a guided surgery and the patient's sinus was perforated.The clinician used a guided surgery software program (believed to be called 'chrome') which is not supported by zb dental.The unauthorized protocol ended up being incorrect and one of the drills used was too long.The hcp perforated a sinus cavity in the maxilla as a result.Based on the information provide, no return product and no radiographs or images, the complaint could not be verified.The root cause of the complaint is related to customer misuse of the product.

• Brand Name: TAPERED NAVIGATOR® CERTAIN® SURGICAL KIT
• Type of Device: DRILL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8671823
• MDR Text Key: 147094813
• Report Number: 0001038806-2019-00479
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGTIKIT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention