MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JUGGERKNOT 1.0MM MINI 2-0 NDLS; FASTENER, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 02/04/2015

Event Type  Injury  

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.This report is number 1 of 4 mdrs filed for the same event (reference 1825034-2015- 00749 / 00752).

Event Description

It was reported that during a right wrist ligament repair utilizing suture anchors on (b)(6) 2015.During the procedure, four anchors were attempted for use unsuccessfully as they pulled out of the patient's bone.Additional suture anchors and competitor product were used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to report device evaluation results.Product was returned for evaluation on (b)(4) 2015.Examination of returned device found no evidence of product non-conformance.Product likely failed due to misuse, by not properly positioning/aligning with the drilled hole causing the mini nitinol pushers to bend during insertion, which would allow the anchors to be pulled out and not set.

Manufacturer Narrative

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

Event Description

It was reported that patient underwent a right wrist ligament repair on (b)(6) 2015 utilizing suture anchors.During the procedure, four anchors were attempted for use unsuccessfully as they pulled out of the patient's bone.Additional suture anchors and competitor product were used to complete the procedure.

• Brand Name: JUGGERKNOT 1.0MM MINI 2-0 NDLS
• 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: 4555301
• MDR Text Key: 21214953
• Report Number: 0001825034-2015-00749
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2015

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 Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 031340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 02/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2015; 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR