MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN TOGGLELOC; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received based on review of a journal article titled, ¿conventional trans-tibial versus anatomic medial portal technique for femoral tunnel preparation in anterior cruciate ligament reconstruction; comparison of clinical outcomes,¿ which examines two methods, conventional trans-tibial drilling of femoral tunnel and anatomic preparation of femoral tunnel through medial portal (mp), in patients who underwent acl reconstruction to determine whether there are any differences in clinical outcomes between the two.The study was conducted over a period of two years and involved 129 patients who underwent acl reconstruction.Three patients were identified in the article that underwent acl reconstruction utilizing a suture anchor.Patient follow up results show that these patients experienced skin infection, which improved with wound care and antibiotics.There has been no further information provided and the patient outcomes are unknown.

• Brand Name: UNKNOWN TOGGLELOC
• Type of Device: FASTENER, 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: 5884059
• MDR Text Key: 52378759
• Report Number: 0001825034-2016-03128
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/17/2016
• 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): Required Intervention