Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X10MM CROSS-DRIVE SCREW, 5PK; PLATE, BONE
  • 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 MICROFIXATION TRAUMAONE SYSTEM 2.0X10MM CROSS-DRIVE SCREW, 5PK; PLATE, BONE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The surgeon reported two possible part numbers 45-2010 or 45-2012.He thought it was 45-2012 but he was not certain.Part#: 45-2010.Brand name: traumaone system 2.0x10mm cross-drive screw, 5pk.Catalog number: 45-2010.Udi number: (b)(4).Part#: 45-2012 brand name: traumaone system 2.0x12mm cross-drive screw, 5pk.Catalog number: 45-2012.Udi number: (b)(4).The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
 
Event Description
It was reported the screw fractured and the screw body remained in the patient during a maxillofacial surgery.The pilot hole was drilled to a specific depth prior to the insertion attempt.The screw was seated flush with the plate and fractured on the final turn when tightening.The head of the screw sheared off the body of the screw.No additional patient consequences were reported.
 
Event Description
It was reported the screw fractured and the screw body remained in the patient during a maxillofacial surgery.The pilot hole was drilled to a specific depth prior to the insertion attempt.The screw was seated flush with the plate and fractured on the final turn when tightening.The head of the screw sheared off the body of the screw.Only three (3) screws were able to be placed instead of four (4), which was described as not ideal in a fracture that requires two (2) screws on either side of the fracture.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.This report is being submitted to update additional information in section b5, d1, d4, h6 and h10.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned screw.The screw has fractured where the screw head meets the screw shaft.A dimensional analysis was unable to be conducted due to the damage to the screw.The complaint is confirmed.A determination cannot be made as to what caused the screw to fracture.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRAUMAONE SYSTEM 2.0X10MM CROSS-DRIVE SCREW, 5PK
Type of Device
PLATE, BONE
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key11018382
MDR Text Key225045386
Report Number0001032347-2020-00617
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
PMA/PMN Number
K081067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number45-2010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-