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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a hand tendon repair procedure on (b)(6) 2015.During the procedure, the suture anchor pulled out while removing the inserter.It was noted the sleeve was torn in two pieces.Another suture anchor was utilized to complete the procedure.

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.There are warnings in the package insert that state that this type of event can occur: under warnings, number 2 states, "improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, the root cause of the event could not be determined.

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent a right hand tendon repair procedure on (b)(6) 2015.During the procedure, the suture anchor pulled out while removing the inserter.It was noted the sleeve was torn in two pieces.Another suture anchor was utilized and a new hole had to be drilled 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: 4871781
• MDR Text Key: 6061055
• Report Number: 0001825034-2015-02759
• 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,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 065330
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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
• Patient Age: 70 YR