• 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. SPDPASS LARIAT W/NIT 45DEG UP; PASSER

  • 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. SPDPASS LARIAT W/NIT 45DEG UP; PASSER Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2015
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).The complaint was confirmed in that the bottom biomet seal had been peeled open.Presence of adhesive transfer as well as the requirements of inspection criteria lead to the assumption that the peeling of the seal occurred after the product left biomet's control, although it cannot be determined.The coob summary in the complaint and review of other parts from the same lot indicate that the 2 parts with the peeled open seal are part of an isolated incident.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional related issues for this item.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
It was reported that when the nurse opened the sterile product, the item fell out of the bottom of the package onto the floor.It never entered the sterile field.The seal on the package was compromised.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPDPASS LARIAT W/NIT 45DEG UP
Type of Device
PASSER
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 Key6932418
MDR Text Key89955646
Report Number0001825034-2017-08279
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/07/2018
Device Model NumberN/A
Device Catalogue Number904008
Device Lot Number961030
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/13/2015
Initial Date FDA Received10/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2013
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 Sequence Number1
-
-