• 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, INC. PHOENIX ANKLE LOCKING NAIL 12 X 150MM ROD, FIXATION

  • 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, INC. PHOENIX ANKLE LOCKING NAIL 12 X 150MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467); Defective Device (2588)
Patient Problem No Code Available (3191)
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4). Customer has been indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded.
 
Event Description
It was reported that there was a defect on the bottom of the nail, which caused the nail to not sit properly on the jig. As a result, the screw holes did not line up properly. This caused misalignment of the screws. A new nail was used and properly assembled and implanted. The procedure was delayed for thirty minutes. No additional patient consequences were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHOENIX ANKLE LOCKING NAIL 12 X 150MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6994124
MDR Text Key119228442
Report Number0001825034-2017-09670
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK091976
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number14-440315
Device Lot Number773130
Other Device ID NumberSEE H10 NARRATIVE
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 Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
-
-