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: ZIMMER BIOMET SPINE INC. TORQUE INDICATING WRENCH (POLARIS 5.5); WRENCH (RATCHETING HANDLES)
  • 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
 

ZIMMER BIOMET SPINE INC. TORQUE INDICATING WRENCH (POLARIS 5.5); WRENCH (RATCHETING HANDLES) Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/16/2018
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that the tip of an indicator torque wrench broke during insertion.The surgeon attempted to retrieve the tip, but could not and decided to leave it in as he does not believe it will lead to any risks for the patient.There was no delay of surgery or further patient harm.
 
Manufacturer Narrative
The returned torque indicating wrench was evaluated.The tip was confirmed to be fractured.The cause of this event can likely be attributed to over-torquing of the device.The labeling was reviewed and found to contain instructions regarding product use, including a note letting the user know that this device does not provide an audible click when the appropriate torque is achieved; instead the indicating lines align when the proper torque is met.
 
Event Description
It was reported that the tip of an indicator torque wrench broke during insertion.The surgeon attempted to retrieve the tip, but could not and decided to leave it in as he does not believe it will lead to any risks for the patient.There was no delay of surgery or further patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TORQUE INDICATING WRENCH (POLARIS 5.5)
Type of Device
WRENCH (RATCHETING HANDLES)
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7875203
MDR Text Key120237248
Report Number3012447612-2018-00763
Device Sequence Number1
Product Code HXC
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number2000-9082
Device Lot Number032782-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age84 YR
-
-