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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Type  Injury  

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.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "return to work in miners following anterior cruciate ligament reconstruction" which retrospectively reviewed miners who had undergone acl reconstruction in order to observe the duration of time off work and reasons for delays for patients to return to work.The study included 33 miners who had undergone acl reconstruction from 2009 to 2014.Patients were identified in the article that underwent acl repair procedures.Effusion of the knee requiring drainage affected the length of time in which it took the patients to return to work.There has been no further information provided and the patient outcomes are unknown.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.The root cause remains undetermined.

Event Description

Information was received based on review of a journal article titled, ¿return to work in miners following anterior cruciate ligament reconstruction¿ which retrospectively reviewed miners who had undergone acl reconstruction in order to observe the duration of time off work and reasons for delays for patients to return to work.The study included 33 miners who had undergone acl reconstruction from 2009 to 2014.Four patients were identified in the article that underwent acl repair procedures.Effusion of the knee requiring drainage affected the length of time in which it took the patients to return to work.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 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: 5886986
• MDR Text Key: 52490936
• Report Number: 0001825034-2016-03143
• Device Sequence Number: 1
• Product Code: MBI
• 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,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• 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
• Date Manufacturer Received: 01/25/2017
• 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