MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BONE DEPTH GAUGE FAST; GUAGE, DEPTH

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 07/10/2014

Event Type  Injury  

Event Description

It was reported that patient underwent bilateral wrist distal volar radius plate procedure on (b)(6) 2014.During the procedure, the depth gauge fractured.An alternative means of screw length measurement was utilized to complete the procedure.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Manufacturer Narrative

This follow-up report is being filed to relay product will not be returned for evaluation.

• Brand Name: BONE DEPTH GAUGE FAST
• Type of Device: GUAGE, DEPTH
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4002034
• MDR Text Key: 4711892
• Report Number: 0001825034-2014-06955
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: FBDG
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 08/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention