MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERLOC BONE TO BONE STAINLESS STEEL KIT; WASHER, BOLT

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem Tissue Damage (2104)

Event Date 09/12/2016

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 the 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 1 states, "correct selection of the implant is extremely important.The potential for success in bone to bone approximation is increased by the selection of the proper type of implant." product code - htn.This report is number 1 of 2 mdr's filed for the same patient (reference 1825034-2016-04092 / 04093).

Event Description

During an open reduction internal fixation of an ankle, suture anchor pulled out and a second hole had to be drilled to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Quantity: (b)(4).

Event Description

During an open reduction internal fixation of an ankle, two suture anchors pulled out and a second hole had to be drilled to complete the procedure.The patient reportedly retained a foreign body.

• Brand Name: JUGGERLOC BONE TO BONE STAINLESS STEEL KIT
• Type of Device: WASHER, BOLT
• 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: 6025465
• MDR Text Key: 57261461
• Report Number: 0001825034-2016-04092
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141219
• 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
• Report Date: 09/14/2016

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 Expiration Date: 06/15/2021
• Device Model Number: N/A
• Device Catalogue Number: 110007337
• Device Lot Number: 566290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR