• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET SPORTS MEDICINE JUGGERLOC BONE TO BONE STAINLESS STEEL KIT; WASHER, BOLT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6025465
MDR Text Key57261461
Report Number0001825034-2016-04092
Device Sequence Number1
Product Code HTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK141219
Number of Events Reported1
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 Date06/15/2021
Device Model NumberN/A
Device Catalogue Number110007337
Device Lot Number566290
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2016
Initial Date FDA Received10/13/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
-
-