MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JUGGERKNOT 1.4MM 1 #1 MB 10PK; FASTENER, FIXATION

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a labral repair procedure utilizing a suture anchor on (b)(6) 2014.During the procedure, a suture anchor appeared to be loose upon attempted implantation.Another suture anchor was used to complete the procedure and a new hole was drilled.There was no significant delay to the procedure as a result.

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.

Manufacturer Narrative

Examination of returned device found the fork tip of inserter to be broken off and missing.Based on the review of device history records and on this investigation, the part left biomet in a conforming to print specification condition and it appears that the conditions of use caused or contributed to the inserter damage.This device requires precise alignment before impacting for anchor deployment, if misaligned inserter damage can occur.

• Brand Name: JUGGERKNOT 1.4MM 1 #1 MB 10PK
• 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: 3915684
• MDR Text Key: 4489060
• Report Number: 0001825034-2014-05952
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 912010
• Device Lot Number: 912460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2013
• 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