• 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. AFFIXUS HFN 125 DEG 11MM X 180MM 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. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has not yet indicated if the product will 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.
 
Event Description
It is reported that during the procedure, the sterile packaging of the nail was found to be opened. Another back up nail was available to successfully complete the procedure. No patient consequences were reported as a result of the malfunction.
 
Manufacturer Narrative
The complaint sample was evaluated and the reported event was confirmed through physical evaluation. The returned product and packaging confirmed that the inner packaging was not sealed, however, showed evidence by the seal marks that the packaging was sealed at some point. The device history records were reviewed and no discrepancies were identified. Upon further review, the root cause of the reported issue was identified as inadequate guidance at the distribution centers to process the returned products. A corrective action has been initiated to address this issue. 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.
 
Event Description
No further event information available at the time of this report.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
The complaint sample was evaluated and the reported event was confirmed through physical evaluation. The returned product and packaging confirmed that the inner packaging was not sealed, however, showed evidence by the seal marks that the packaging was sealed at some point. The device history records were reviewed and no discrepancies were identified. The root cause was determined to be inadequate work procedures/instructions and distribution not integrated into the company¿s quality management system. 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.
 
Event Description
Additional product information received.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAFFIXUS HFN 125 DEG 11MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7895254
MDR Text Key120977235
Report Number0001825034-2018-09036
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup,Followup
Report Date 06/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814311180
Device Lot Number287720
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

-
-