MAUDE Adverse Event Report: BIOMET ORTHOPEDICS PEG SCREW; APPLIANCE, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a foot / metatarsal procedure on an unknown date.Subsequently, a revision procedure has been indicated to secure the metatarsal fusion plate with screws that have backed out.No revision procedure has been reported to date.

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.The following sections could not be completed with the limited information provided: catalog number, lot number, and expiration date.Implant date.Explant date.510k number.Device manufacture date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.A review of the initial invoice revealed that six fully threaded screws and two peg screws were implanted with the plate.Invoice history for the revision procedure indicated two fully threaded screws and one peg screw was implanted, which suggests that two fully threaded screws and one peg screw was removed due to backing out.The event was attributed to patient poor bone quality and is therefore being reported on one medwatch as the exact product identification of the screws removed has not been provided.

Event Description

It was reported the patient received a metatarsal fusion plate on (b)(6) 2014.Subsequently, the patient underwent a revision procedure on (b)(6), 2014 due to screws backing out caused by poor bone quality.Three screws were removed and replaced.

• Brand Name: PEG SCREW
• 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: 4214398
• MDR Text Key: 4997295
• Report Number: 0001825034-2014-08453
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• 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
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR