• 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 SOLITAIRE TI 25MM U-JOINT AWL

  • 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 SOLITAIRE TI 25MM U-JOINT AWL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2016
Event Type  Malfunction  
Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

 
Event Description

It was reported that during surgery, the depth stop ring of a u-joint awl broke off and fell into the wound. It was promptly removed so the patient did not retain a foreign body. A different instrument was used to complete the procedure. There was a 30 minute delay to the procedure to remove the broken piece, but there were no reports of patient injury associated with this event.

 
Manufacturer Narrative

The device was not returned for evaluation. A review of the manufacturing records did not identify any issues which would have contributed to this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOLITAIRE TI 25MM U-JOINT AWL
Type of DeviceAWL
Manufacturer (Section D)
ZIMMER BIOMET SPINE
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer Contact
geoffrey gannon
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key6099811
MDR Text Key59791196
Report Number3004485144-2016-00310
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
PMA/PMN NumberPEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number1400-9133
Device LOT NumberPR27E
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-