MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 2.2MM LOCKING DRILL GUIDE; FIXED ANGLE SCREW TARGETING, DRILL GUIDE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 03/12/2015

Event Type  Injury  

Event Description

It was reported that during a distal volar radius plate procedure the surgeon noticed the plate to be too lateral so he decided to change its position.While attempting to re-implant without the guide positioned the screws incorrectly.The guides were replaced and the plate and screws were successfully re-implanted.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.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.(b)(4).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted that the mating part was not returned and the failure was unable to be recreated.The root cause of the event could not be determined.

• Brand Name: 2.2MM LOCKING DRILL GUIDE
• Type of Device: FIXED ANGLE SCREW TARGETING, DRILL GUIDE
• 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: 4700557
• MDR Text Key: 5725554
• Report Number: 0001825034-2015-01530
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• 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: 231200109
• Device Lot Number: NW140042
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention