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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

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.Implant date in 2016.The following sections could not be completed with the limited information provided.Product code - ni.Expiration date - ni.

Event Description

It is reported that a patient underwent a sports medicine procedure during which a snapshot device was implanted.Patient was subsequently revised due to biceps rupture below the device on an unknown date.The device was reportedly still in place.No further information has been provided.

• Brand Name: UNKNOWN BIOMET SNAPSHOT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6355997
• MDR Text Key: 68218781
• Report Number: 0001825034-2017-00887
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/24/2017
• 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