MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.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: 0001032347-2019-00021 through 0001032347-2019-00024.

Event Description

It was reported the depth gage was broken.No adverse events have been reported as a result of the malfunction.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The product identities were confirmed.The 2.0 mm/ 2.4 mm system 45 mm, long, depth gage (part# 01-9125, lot #: 612980, serial# 413328) was visually evaluated.The gage showed signs of use with some scratches at the base of the handle and a bent gage guide.The depth gage cannot provide an accurate depth measurement with a bent guide, therefore the complaint is confirmed.The most likely underlying cause of the complaint is excessive force was applied.The device history record (dhr) was reviewed and no discrepancies were found.In the warnings and precautions section of the instructions for use (ifu) for this product it is stated, 'avoid undue stress or strain when handling or cleaning instruments.' the discoloration is most likely due to residual from the cleaning process.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00022-1, 0001032347-2019-00022-1, 0001032347-2019-00024-1, and and 0001032347-2019-00067.

• Brand Name: 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE
• Type of Device: DEPTH GAGE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8233115
• MDR Text Key: 132796359
• Report Number: 0001032347-2019-00021
• Device Sequence Number: 1
• Product Code: EIL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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
• Device Lot Number: 612980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1