MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MD SCREW 2.7MM X 24MM STE; APPLIANCE, FIXATION

Model Number N/A

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 09/22/2014

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Exact event date and date of explant are unknown.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.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014- 08430 / 08431).

Event Description

It was reported that patient underwent orif, open reduction internal fixation, of a distal radial fracture on (b)(6) 2014.A multi-directional screw was placed into the radial styloid and locked into the plate.On a later radiograph it was found to have backed out of the plate.The plate and all screws were later removed and replaced with a different plate on an unknown date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch:.

Event Description

It was reported that patient underwent orif, open reduction internal fixation, of a distal radial fracture on (b)(6) 2014.A multi-directional screw was placed into the radial styloid and locked into the plate.On a later radiograph it was found to have backed out of the plate.The plate and all screws were later removed and replaced with a different plate on (b)(6) 2014.

Manufacturer Narrative

Evaluation of the returned screw found evidence to suggest that it was off center and at an angle outside the 20° which contributed to inadequate engagement of the screw, resulting in the post-surgical back out.The likely condition of the product when it left biomet control was conforming.

• Brand Name: MD SCREW 2.7MM X 24MM STE
• Type of Device: APPLIANCE, FIXATION
• 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: 4217180
• MDR Text Key: 21850884
• Report Number: 0001825034-2014-08414
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 131827324
• Device Lot Number: 174769
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention