MAUDE Adverse Event Report: BIOMET MICROFIXATION DEPTH GAGE 2.0/2.4 45MM LONG; GAUGE, DEPTH, INSTRUMENT, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

Device product code: eil.Current information is insufficient to permit a valid conclusion about the cause of this event; a follow-up report will be sent upon completion of the device evaluation.

Event Description

It was reported the tip of the depth gauge broke in the patient's mouth.The surgeon tried to remove the piece but was not successful.Less than one millimeter of the tip remained in the right side of the patient's mandible.The surgeon stated there will be no revision to remove the tip as they feel the tip does not present any danger to the patient.There was no delay to the procedure that exceeded ten minutes.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned without packaging.The instrument was visually evaluated and found to have a section of the depth gauge spike broken off.When the spike is slid, the remaining portion of the spike begins to exit the guide at 18 mm, indicating the section of the tip broken off was roughly 18 mm in length.The instrument is in good overall cosmetic condition with scratches and normal signs of wear from use; slight discoloration was observed on the handle and the interface between the spike and slide.The manufacturing history was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to excessive force applied by the user.The spike is delicate as the tip tapers from.034¿ to.022¿ thick.A summary of the investigation will be sent to the complainant conveying proper surgical technique and use of the device.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.Based on the product evaluation, the following fields were updated: report date to reflect the date of this report.Date received by mfr to reflect the date the product evaluation as completed.Type of reports to reflect this is follow up report #1.If follow-up, what type? to reflect the reason for the follow-up report.Device evaluated by mfr? to reflect the product evaluation is completed.(b)(4).Additional mfr narrative to reflect relevant additional information.

• Brand Name: DEPTH GAGE 2.0/2.4 45MM LONG
• Type of Device: GAUGE, DEPTH, INSTRUMENT, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6745294
• MDR Text Key: 81111674
• Report Number: 0001032347-2017-00594
• Device Sequence Number: 1
• Product Code: EIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 01-9125
• Device Lot Number: 535681
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability