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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2024

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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 is reported that the instrument was discovered fractured during restocking.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 corrected h6 - health impact.A visual inspection was conducted on the returned depth gauge.The gauge shows signs of multiple uses including heavy marking and scratching on the gauge surface.Further inspection was conducted on the gauge tip.The tip for the depth gauge has fractured.The fractured version on the depth gauge was not returned.A determination cannot be made as to what caused the device to fracture.Dhr review was not performed as product has approximate field age of 15 years, with an unknown number of uses.The device shows signs of repeated use.A definitive root cause cannot be determined.The reported event is confirmed, based on evaluation of the returned product.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: 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18922980
• MDR Text Key: 337896876
• Report Number: 0001032347-2024-00095
• Device Sequence Number: 1
• Product Code: ILE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-9125
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1