MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE WASHERLOC TISSUE FIXATION 16MM; FASTENER, FIXATION

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2016

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "bending or fracture of the implant." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00723 / 01384).

Event Description

It was reported that patient underwent an anterior crucial ligament reconstruction procedure on (b)(6) 2009.Subsequently, patient underwent an anterior crucial ligament revision procedure due to unknown reasons utilizing a hex screwdriver on (b)(6) 2016.During the procedure, the tip of the screwdriver fractured while the surgeon was removing the washerloc.The fractured portion of the screwdriver did not fall into the patient and the patient did not retain any foreign bodies.The procedure was completed with a competitor screwdriver.This resulted in a delay of five (5) to ten (10) minutes.Additional information received reported the patient was revised on (b)(6) 2016 due to an anterior crucial ligament tear.Operative report noted metal shavings had been visualized in an x-ray of the right knee.

• Brand Name: WASHERLOC TISSUE FIXATION 16MM
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 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: 5597523
• MDR Text Key: 43310256
• Report Number: 0001825034-2016-01384
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 908436
• Device Lot Number: 009110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2008
• 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; Disability
• Patient Age: 24 YR
• Patient Weight: 80