MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERKNOT 1.4 SHORT W/ NDLS; FASTENER, FIXATION

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

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.The following could not be completed with the limited information provided.Date of event ¿ ni, expiration date ¿ ni, manufacture date ¿ ni.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-04640 / 04641).

Event Description

During a procedure, the anchor pulled out and new anchor was implanted into the same hole with no delay in the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

During the procedure, while deploying the anchor, the anchor pulled out and a new anchor was implanted into the same hole.There was a 20-30 min delay to use a new device to complete the procedure.

• Brand Name: JUGGERKNOT 1.4 SHORT W/ NDLS
• 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: 6093592
• MDR Text Key: 59630120
• Report Number: 0001825034-2016-04640
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 912068
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• 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): Required Intervention